Implant comprising an expandable section

ABSTRACT

Penile implant and system comprising such an implant. The penile implant comprises a number of features which improves the function of the penile implant, e.g. a certain surface structure and portions with specific functions.

TECHNICAL FIELD

The present invention relates to an implantable device, in particular anadjustable implantable device, in particular a penile implant for curingerectile impotence, a system comprising such a device and methods ofimplanting such a device and system.

BACKGROUND

As regards implants, and in particular adjustable implants and penileimplants for curing erectile impotence, known from the background art,there are a number of areas or aspects where there is mom forimprovement.

One problem often encountered is the formation of fibrotic tissue oraccumulation of fibrotic cells on the surface of the implant. Theformation of such tissue on the surface of an adjustable implant or apenile implant may negatively influence the function of the implant,e.g. if such tissue is formed on a part of the surface that iscollapsible and/or expandable.

In the background art expandable/collapsible breast implants are known,see e.g. US-B1-6,875,233. The pleats of the implant described in thisdocument may be prone to be bridged by fibrotic tissue which may impedethe function of the implant further, the technique shown in thisdocument may be unsuitable for use in an implant e.g. a penile implantsince the conditions and demands may differ between penile implants andbreast implants.

See also U.S. Pat. No. 4,424,807 which shows a penile implant where thefolded or overlapped portions 50 and the folded ends 44 and 46 may beprone to be bridged or covered by fibrotic tissue which may impede thefunction of the implant.

Another problem often encountered with previously known implants, e.g.in connection with organ or breast implants and especially in connectionwith penile implants, is that there is a risk that the implant breaks orgets damaged when it is subjected to bending, pressure or otherinfluence. An adjustable implant may e.g. be subjected to suchinfluences in its relaxed or inactivated state and/or in its expanded oractivated state and this may cause breaking or other damage. A penileimplant is e.g. often subjected to bending in its relaxed state and inthe bended area there is an evident risk of damage or breaking of thepenile implant. See e.g. U.S. Pat. No. 4,424,807 which shows a penileimplant subjected to bending in its relaxed state.

One further problem often encountered with previously known penileimplants is that the angle of the penis when activated by the penileimplant is unnatural and does not correspond to the angle of an erectednormally functioning penis. A normally functioning penis is bent upwardto some extent, there are of course individual variations, when erectedbut previously known penile implants often result in an erected penisthat is not bent upwards but solely stands straight out from the bodyunder an angle of approximately 90 degrees. See e.g. U.S. Pat. No.4,424,807 which shows a previously known penile implant as described.

Another problem often encountered with previously known implants,especially in connection with penile implants, is that a quite largeamount of hydraulic fluid is needed to fill the implant when the implantis activated. This leads to a delay in the activation of the implant andto a relatively large reservoir for the hydraulic fluid. The larger thereservoir for the hydraulic fluid is, the more difficult it is toinvasively place it in the body, e.g. in the scrotum, and potentiallythe more inconvenient it is for the patient to have the reservoirinvasively placed in the body. To have a large amount of hydraulic fluidin the activated penile implant also makes the penile implant heavywhich may be dissuitable. See e.g. U.S. Pat. No. 4,424,807 which shows apreviously known penile implant as described. To have a large amount ofhydraulic fluid in an activated adjustable implant also makes theimplant unnecessarily heavy, which may be disadvantageous. See e.g. U.S.Pat. No. 4,424,807 or US-B1-6,875,233 which show previously knownimplants as described.

Another problem often encountered with previously known penile implantsis that there is no radial or longitudinal expansion of the penileimplant when filled with hydraulic fluid. In contrast, a natural corpuscavernosum undergoes a radial and longitudinal expansion when filledwith blood. There is previously known penile implants having provisionsfor radial and longitudinal expansion, see e.g. U.S. Pat. No. 4,424,807,but these provisions have less favorable characteristics in certainaspect. In the case of U.S. Pat. No. 4,424,807, as mentioned before, thefolded or overlapped portions 50 and the folded ends 44 and 46 may beprone to be bridged or covered by fibrotic tissue.

A further problem with previously known implants is that they do notprovide any remedy for dysfunctional ejaculation.

Also other solutions than those cited above are known in this field, oneknown solution to achieve erection is to restrict the blood flow leavingthe penis. For example, U.S. Pat. No. 4,828,990 discloses twohydraulically operated inflatable cuffs wrapped around respective cruraor veins. A disadvantage of such a solution is that it involvescomplicated surgery.

Another known solution according to U.S. Pat. No. 4,828,544 comprises anartificial fistula system surgically implanted and providing a primaryfistula between the femoral artery and the femoral vein and a secondaryfistula for leading blood from the primary fistula to the penis. Aninflatable balloon engages the primary fistula between the secondaryfistula and the vein. The balloon is in fluid connection with a manuallycompressible reservoir implanted in the scrotum. Again, implantation ofthis artificial fistula system requires delicate surgery. Anotherdisadvantage, to such a solution, is the fact that the venous bloodvessel system is rather complex and it is difficult to restrict the veinplexa.

Yet another known solution, for example disclosed in U.S. Pat. Nos.3,855,122, 3,954,102, 4,009,711, 4,201,202, 4,235,222, 4,318,396,5,250,020 and 4,424,807, currently practised is to replace the corpuscavernosa in the penis with a hydraulic inflatable/contractable siliconeprosthesis thus implanted in the penis. In fluid connection with thisprosthesis is a balloon-like reservoir implanted in the scrotum. Bymanual pumping action the prosthesis is filled with fluid from thereservoir to effect errect penile condition or is emptied of fluid,which returns to the reservoir, to effect flaccid penile condition.

Another problem often encountered with previously known implants is thatthey are not adjustable in size in a convenient or satisfactory way.

It is an aim to provide a technique that leads to improvement regardingall or at least some of the areas or aspects discussed above.

SUMMARY

According to one aspect of the invention there is provided a surfacestructure for an implant, e.g. an adjustable implant, and an implantabledevice or implant having such a surface structure. The surface structurehas defined distances between the elements of the structure. Thedistances are big enough to prevent or limit fibrotic tissue frombridging the elements or connecting the elements in such a way as toimpede the function of the implant.

According to one aspect of the invention there is provided a surfacestructure for an penile implant, especially an elongated penile implantor penile prosthesis for curing erectile impotence, and an implantabledevice having such a surface structure, where the surface structure hasdefined distances between the elements of the structure. The distancesare big enough to prevent or limit fibrotic tissue from bridging theelements or connecting the elements in such a way as to impede thefunction of the implant.

Fibrotic tissue can often have an extension or thickness of about 0.5 mmto about 1.5 mm and hence the distances between relevant surfaces of theelements of the surface structure are suitably greater than about 3 mm,hence greater than about 2×1.5 mm. But depending on the circumstancesalso distances greater than about 1.0 mm to about 3 mm may besufficient. In cases where the fibrotic tissue can be expected to havean extension or thickness greater than about 1.5 mm the distancesbetween relevant surfaces of the elements of the surface structure areadapted in a suitable manner.

The surface structure may comprise elevated and lowered areas and it maybe suitable that also a distance between the different planes of theelevated and lowered areas is bigger than a certain threshold tofacilitate the collapsible and/or expandable functionality of theimplant. If said distance is too small, the collapsible and/orexpandable functionality of the implant may be limited. A suitableinterval for said distance is around 0.5 to 10 mm, more suitable around2-8 mm and most suitable around 3-7 mm The surface structure maycomprise different geometrical elements or shapes and any combination ofsuch elements or shapes as long as the above mentioned conditions forthe distances can be met. The surface structure may e.g. comprise ridgesand grooves of different shapes. The ridges and grooves may each have across-section that is e.g. wedge-shaped, polygonal, square-formed,pyramidal-shaped, truncated pyramidal-shaped or. Further may the ridgesand grooves have cross-sections of different shape. The surfacestructure may as well in general comprise a bellows-shaped structure ora surface structure where geometrical objects of the same or differentkind(s) are placed on a surface. The geometrical objects may bepractically randomly placed on the surface or according to some scheme.

One type of implants where this type of surface structure is suitable,is implants where the implant should have the ability to change shapeand/or size substantially, e.g. penile implants. Hence, this is a casewhere the presence of fibrotic tissue substantially could hinder orimpede the function of the implant. But the surface structure may beused by any implant where the characteristics of the surface structurewould be suitable for the implant.

According to another aspect of the invention there is provided animplant or implantable device e.g a penile implant or penile implantabledevice, in particular an elongated penile implant or penile prosthesisfor curing erectile impotence, having a pre-formed section. Thepre-formed section may suitably comprise a surface shape having at leastone fold, pleat or bellow shaped part or part having a smooth surface,or combinations thereof. This to mention some examples. The pre-formedsection is suitably in a position or area where the penile implant oftenis bent. For a penile implant one suitable position for the pre-formedsection is a point or area of the penile implant which is in thevicinity of and/or including the position where the protruding part ofthe penis starts. With the protruding part of the penis it is meant thepart of the penis that is visible on the outside of the body, alsocalled pendulous part. Suitably the pre-formed section is shaped in away as to give the penile implant a shape that corresponds to orresembles the shape that the penile implant has most of the time. Thismay be suitable to minimize the stress on the material of the implant.In the case of a penile implant it can e.g. be assumed that the penileimplant is relaxed most of the time. Hence, it is suitable that thepre-formed section is shaped in a way as to give the penile implant ashape that corresponds to or resembles the shape of a relaxed penis. Thepre-formed section suitably has a certain extension in the longitudinaldirection of the penile implant, here called longitudinal extension. Thelongitudinal extension of the pre-formed section is suitably in theinterval of around 5-150 mm, depending on the circumstances, e.g. thelength of the penile implant. It may be suitable that the pre-formedsection has a longitudinal extension that is around 10-40 percent of thetotal longitudinal extension of the penile implant. The pre-formedsection may comprise a substantially saw tooth shaped surface, or anyother suitable surface shape which enables an appropriate function ofthe pre-formed section, e.g. any of the surface shapes or elementsdescribed in the section of this application regarding the surfacestructure having elevated and lowered areas. The surface shape(s) of thepre-formed section may extend along a part of, part of or the completecircumference of the pre-formed section. In the case of a substantiallysaw tooth shaped surface, or any other surface shape comprising ridgesand grooves, e.g. a square wave shaped surface or a wave shaped surface,it is suitable that the ridges and grooves extend in a substantiallycircumferential direction of the penile implant and that the ridges andgrooves are placed alternating one after the other in a substantiallylongitudinal direction of the implant. By providing an implant, inparticular a penile implant, with a pre-formed section as described, therisk for breaking of, or damage to, the penile implant is reduced andmay even be substantially eliminated.

According to another aspect of the invention there is provided an penileimplant or penile implantable device, in particular an elongated penileimplant or penile prosthesis for curing erectile impotence, comprisingbending portion giving the penile implant a desired angle whenactivated, e.g. filled with hydraulic fluid. For a penile implant saidbending portion gives the activated penile implant an upwardly bentposition. That is, when said penile implant is invasively placed in thecorpus cavernosum, suitably one penile implant in each corpuscavernosum, in the penis of a standing person, frequently a man, andactivated, said implant, and hence also the penis, assumes an upwardlybent position. With upwardly bent is meant that the penis has an acuteangle with a vertical plane, said angle being measured from the upperside of the penis towards a vertical plane when said person is standing.Suitably said vertical plane is substantially parallel with the body ofsaid standing person. Said bending portion may e.g. comprise that thepenile implant has a bellows structure and/or a pliable wall part atleast in the area where the penile implant is bent, or should be able tobe bent further, the bending portion, e.g. a bellows structure or apliable wall part, on one side of the penile implant is designed to showa greater length expansion when the penile implant is activated than thebending portion on the other side of the implant. Said bending portionmay e.g. be positioned at a point or in an area of the penile implantwhich is in the vicinity of and/or including the position where theprotruding part of the penis stark. The bending portion that should showa greater length expansion when the penile implant is activated may e.g.have a greater area. This may e.g. be achieved in that the bendingportion has a greater longitudinal extension on one side of the penileimplant than on the other side. Another possibility is that, in case ofa bellows structure, the bellows structure has a greater depth, at leastwhen the penile implant is in or non-activated, on one side of thepenile implant than on the other side, to enable a greater lengthexpansion of the bellows structure having the greater depth. These twopossibilities may of course also be combined. In the A bellows structureoften has a surface structure which can be said to comprise ridges andgrooves. For measuring the depth of a bellows structure one may measurethe distance between the bottom of a groove and the top of a ridge. Withlength expansion is meant an expansion in the longitudinal direction ofthe implant, with longitudinal extension it is meant an extension in thelongitudinal direction of the implant. Said device suitably comprises arelatively short proximal portion, which is to be anchored in the mot ofthe penis, or placed in the part of the corpus cavernosum that islocated inside the body, and a flexible relatively long, distal portion.Said distal portion suitably extends along the pendulous part of thepenis, wherein said bending portion is positioned at or on said proximalportion, suitably in the vicinity of the position where said proximalportion and said distal portion meet. Suitably the distal portion islonger than the proximal portion, as is indicated by the expressions“relatively short proximal portion” and “relatively long, distalportion”. The longitudinal extension of the bending portion is suitablyin the interval of around 5-150 mm, depending on the circumstances, e.g.the length of the penile implant. It may be suitable that the bendingportion has a longitudinal extension that is around 10 to 40 percent ofthe total longitudinal extension of the penile implant. The depth of thebellows structure is suitably in the interval of around 0.5 to 5 mm,even more suitable around 14 mm and most suitably around 1.5-3 mm,depending on the circumstances, e.g. the desired angle of the penis whenthe penile implant is activated.

The bending portion may comprise a substantially saw tooth shapedsurface, or any other suitable surface shape which enables anappropriate function of the bending portion, e.g. any of the surfaceshapes or elements described in the section of this applicationregarding the surface structure having elevated and lowered areas. Thesurface shape(s) of the bending portion may extend along a part of,parts of, or the complete, circumference of the bending portion. In thecase of a substantially saw tooth shaped surface, or any other surfaceshape comprising ridges and grooves, e.g. a square wave shaped surfaceor a wave shaped surface, it is suitable that the ridges and groovesextend in a substantially circumferential direction of the penileimplant and that the ridges and grooves are placed alternating one afterthe other in a substantially longitudinal direction of the implant.Evidently, to achieve the desired effect the penile implant should beinvasively placed in the corpus caverno sum so that the bellowsstructure designed to show the greater length expansion when the penileimplant is activated, is on the underside of the penile implant. It isalso possible that the bellows structure covers a part, or parts, of thecircumference of the implant. The bellows structure may e.g.substantially only cover the underside of the implant, or it maysubstantially cover the underside and the upper side but not the sidesof the implant. The reference for the expressions “underside” and “upperside” is the situation that the penile implant is placed in the corpuscavernosum of a standing person, frequently but not necessarilyexclusively, a standing man in the case of a penile implant. Oneadvantage with said bending portion is that the penis will have anatural angle when the penile implant is activated. This is an advantagee.g. since it is more comfortable for the patient when the penis has anatural appearance in its erected state and since sexual intercourse canbe performed in a more natural way.

According to a further aspect of the invention there is provided animplant or implantable device, e.g. an adjustable implant or implantabledevice, e.g. an penile implant or penile implantable device, inparticular an elongated penile implant or penile prosthesis for curingerectile impotence, where the implant comprises a hollow part comprisinga foam or a similar material, hereafter called foam material. The hollowpart may e.g. be implemented in that the implant itself is hollow orcomprises a hollow body. The hollow part can be filled with atransportable medium to activate the implant. The transportable mediummay e.g. be a fluid such as a gas or a liquid. Suitably the foammaterial is transparent for or to fluid and occupies at least part ofthe volume defined by the hollow part. Transparent for or to fluid meansthat the foam material comprises or defines open spaces that can befilled with fluid. In this way the amount of transportable medium thatis needed to fill the hollow part is reduced as compared to the casewhere the hollow part has to be completely filled with the transportablemedium. This is an advantage e.g. since the weight of the implant whenactivated is reduced and the hollow part can be filled withtransportable medium more quickly. This is suitable for the patienthaving the implant implanted. To further reduce the weight of theimplant when activated, the foam material may comprise a closed cellularfoam material comprising closed spaces containing a, suitably lowdensity, solid material, gas or fluid, e.g. air or foam material.

Foam materials of the closed cellular type have pores or cells that arenot interconnected and are sealed off to an external surface. Hence, theinside of the closed spaces do not come in contact with thetransportable medium. Suitably the foam material comprises a flexiblefoam material.

According to yet another aspect of the invention there is provided animplant or implantable device, e.g. an adjustable implant or implantabledevice, e.g an penile implant or penile implantable device, inparticular an elongated penile implant or penile prosthesis for curingerectile impotence, where the implant is adjustable in size between acollapsed state and an expanded state. Suitably the implant comprises atleast one expandable portion. The implant may also be adjustable in sizebetween a collapsed state and one or more expanded states. In theexpanded states the implant may be fully or partly expanded.

To achieve that the implant can have the desired flexibility,consistence, rigidity or stiffness for the application at hand, e.g. abreast or penile implant, also when the implant is in a partly expandedstate, the expandable portion may be designed or adapted to present thenecessary stiffness already when the expandable portion is partlyexpanded, and to achieve that the penile implant has the requiredstiffness to make the penis erect and hard also when the penile implantis in a partly expanded state, the expandable portion suitably isdesigned or adapted to present the necessary stiffness already when theexpandable portion is partly expanded. This may be achieved by designingthe expandable portion so that it presents an appropriate resistanceagainst further expansion already when the expandable portion is partlyexpanded. The higher resistance an object presents against expansion,the greater the stiffness of the object is. The material and/or thesurface structure of the expandable portion may e.g. have thecharacteristic that it from a certain degree of expansion has therequired stiffness and may be further expanded up to full expansionwhile maintaining the same, or substantially the same, stiffness.Another way of achieving the characteristic that the implant has therequired stiffness to make e.g. the penis erect and hard also when theimplant is in a partly expanded state will now be described. It isassumed that the penile implant comprises a hollow part adapted to befilled with a fluid, the hollow part may be realized in that the penileimplant itself is hollow or it may comprise a hollow body. The hollowpart is divided in compartments separated by dividing wall(s) having avalve which at a first side opens for fluid flow from the first sidewhen the fluid pressure at the first side exceeds a certain pressurevalue but otherwise is closed for fluid flow from the first side. At thesecond side of the valve the valve opens for fluid flow from the secondside already when the fluid pressure at the second side is very low,suitably at substantially zero pressure. This to enable emptying thecompartment on the second side and collapsing an invagination, thecompartment on the second side of the wall has at least oneinvagination. In this way a first compartment on the first side of adividing wall can be filled and pressurized with fluid to make theimplant hard and stiff at a first size, and by further increasing thepressure of the fluid a second compartment on the second side of adividing wall can be filled and pressurized with fluid to make theimplant hard and stiff at a second, greater size when the invaginationbulge due to the fluid pressure. Suitably the first compartment isadapted to always be filled and pressurized with fluid when the implantis activated. Of course more than two compartments may be used wheredividing walls separate the different compartments and where the valvesin the different dividing walls have increasing pressure thresholdsstarting with a first valve in a first dividing valve between the firstand the second compartment having the lowest threshold. In this way itcan be achieved that when such an implant is implanted in the corpuscavernosum, suitably one implant in each corpus cavernosum, theimplant(s) can be activated in steps to make the penis erect and hard atseveral different sizes of the penis, both regarding diameter andlength.

The invagination of the second compartment may also e.g. be a bendingportion which makes it possible to selectively activate, or to differentdegrees activate, the bending portion. There may also be several suchbending portions located around the circumference of the penile implant,this makes it possible to selectively activate different bendingportions to achieve an erected penis that is bent not only upwards butalso to either side or downwards, if this should be desired.

With an implant of any of the designs described above, it is as saidpossible to achieve that the implant can be activated to reach a desireddegree of flexibility, rigidity or stiffness at different sizes of theimplant, e.g. at sizes from 60% to 100% or from 80% to 100% of themaximum size of the implant.

In the case of a organ implant it may comprise a radially expandableportion and/or a longitudinally expandable portion to enable anenlargement and/or an elongation or extension of the organ when theimplant is placed in the and activated and/or expanded. Said sectionsmay each comprise a bellows structure, respectively a radial and alongitudinal bellows structure. Said expandable portions may havedifferent surface structures and/or cross sections.

In the case of a breast implant it may comprise . . . .

-   -   In general, the expandable portions may comprise any suitable        surface shape which enables an appropriate function of the        section(s), e.g. any of the surface shapes or elements described        in the section of this application regarding the surface        structure having elevated and lowered areas.

The radially expandable portion is suitably located on the part of theimplant that is adapted to be placed in the protruding or pendulous partof the organ. The longitudinally expandable portion may be located onthe part of the implant that is adapted to be placed in the part of theorgan that substantially extends on the inside of the body, also calledthe mot of the organ, and/or on the part of the implant that is adaptedto be placed in the protruding or pendulous part of the organ. Theimplant may suitably comprise a relatively short proximal portion and aflexible relatively long distal portion. Suitably the proximal portionis to be anchored or located in the root of the organ and the distalportion is to be located in or to extend along the pendulous part of theorgan. Me radially and the longitudinally expandable portion may also belocated to partly overlap each other. Both sections may e.g. be locatedon the distal portion, the longitudinally expandable portion suitably onthe part of the distal portion which is in the vicinity of the positionwhere the proximal and distal portion meet, and the radially expandableportion suitably extend along substantially the whole distal portion.Depending on the desired shape of the organ when the implant is in anexpanded state the radially expandable portion may also extend alongonly a part of the distal portion. The part of the implant that isadapted to be placed in the vicinity of or at the position of the glansorgan may e.g. have no radially expandable portion or a radiallyexpandable portion with smaller or greater possible radial expansionthan the rest of the radially expandable portion.

The longitudinal extension of the longitudinally expandable portion whenthe implant is in its collapsed state is suitably in the interval ofaround 5-100 mm, depending on the circumstances, e.g. the desiredpossible prolongation or extension when the implant is expanded and thelength of the implant in its collapsed state. It may be suitable thatthe longitudinally expandable portion has a longitudinal extension thatis around 10 to 40 percent of the total longitudinal extension of theimplant. The depth of the bellows structure of the longitudinallyexpandable portion when the implant is in its collapsed state issuitably in the interval of around 0.5 to 5 mm, even more suitablearound 1-4 mm and most suitably around 1.5-3 mm, depending on thecircumstances, e.g. the desired possible prolongation or extension whenthe implant is expanded and the length of the implant. For measuring thedepth of a bellows structure one may measure the distance between thebottom of a groove and the top of a ridge.

The longitudinal extension of the radially expandable portion has beendiscussed above. When the implant is in its collapsed state a suitableinterval for the longitudinal extension of the radially expandableportion is around 5-250 mm, depending on the circumstances, e.g. thelength of the distal part of the implant in its collapsed state. It maybe suitable that the radially expandable portion has a longitudinalextension that is around 80 to 100 percent of the total longitudinalextension of the distal part of the implant. The total depth orextension of the concavenesses or indentations of the radiallyexpandable portion when the implant is in its collapsed state issuitably in the interval of around 5 to 70 mm, depending on thecircumstances, e.g. the desired diameter of the implant in the collapsedstate and in an expanded state. It may be suitable that the total depthor extension of the concavenesses or indentations of the radiallyexpandable portion is around 40 to 60 percent of the circumference ofthe implant in its collapsed state when not including the extension ofthe concavenesses or indentations when calculating the circumference.

Suitably the implant or implantable device comprises at least one hollowsection or hollow body in all of the described aspects. The at least onehollow section or hollow body may be expandable and/or collapsible andmay extend along the whole length, or part of the length, of theimplantable device.

The implantable device may also comprise a transportable medium adaptedto be received into the at least one hollow section or hollow body, orto be withdrawn from the at least one hollow section or hollow body, inorder to activate respectively inactivate the implantable device.

The at least one hollow section or hollow body may suitably be adaptedto receive the transportable medium, and adapted so that thetransportable medium can be withdrawn from the hollow section or hollowbody, in order to activate respectively inactivate the implantabledevice.

The implantable device may be placed in the by any suitable knowntechnique, e.g. by surgically forming a passageway in the and thenplacing or locating the implantable device in the passageway.

According to yet a further aspect of the invention there is provided aorgan prosthesis system for curing erectile impotence where the systemcomprises at least one implant or implantable device as describedherein. Suitably the system comprises two implants or implantabledevices. Such a system suitably includes an operation device connected,suitably by a conduit, to the at least one implantable device. Theoperation device may comprise a fluid reservoir and a pump bothconnected to the at least one implantable device by a conduit so thatfluid can be pumped to and from the implantable device(s). The pump maybe manually operated or powered by an energy source. The system may aswell comprise a control device connected to the operation device,suitably to the pump but it may as well be connected to the fluidreservoir. The control device may transmit control signals and/orpowering signals to the pump and/or the fluid reservoir.

In the text describing the system, e.g. a organ prosthesis system, it isstated that different part is or are for operating or regulating theimplant or implantable device. This implies e.g. that these differentpart are adapted to fill and pressurize the implantable device andmentioned part of the implantable device with a transportable medium,e.g. a fluid. This implies e.g. also that these different part areadapted to withdraw a transportable medium, e.g. a fluid, from theimplantable device and mentioned part of the implantable device.Mentioned part of the implantable device are e.g. the expandablesection, the pre-formed section, the bending portion, the radiallyexpandable portion, the longitudinally expandable portion, the first andsecond compartment, the first and second hollow portions and the hollowbody.

According to yet another aspect of the invention there is provided amethod for invasively placing said implantable device in the of a organ.

As mentioned, said implantable device may suitably be an implant ororgan prosthesis for curing erectile impotence and adapted to beimplanted in the of a organ.

With a penile implant of any of the designs described above, it is assaid possible to achieve that the penile implant, or implants sincenormally one penile implant is placed in each corpus cavernosum, can beactivated to make the penis erect and hard at different sizes of thepenis, e.g. at sizes from 60% to 100% or from 80% to 100% of the maximumsize of the penis. The maximum size of the penis corresponds to thestate when the at least one implant, placed in the corpus cavernosum ofthe penis, is fully expanded.

Generally, suitably the penile implant comprises a radially expandableportion and/or a longitudinally expandable portion to enable anenlargement and/or an elongation or extension of the penis when thepenile implant is placed in the corpus cavernosum and activated and/orexpanded. Said sections may each comprise a bellows structure,respectively a radial and a longitudinal bellows structure. Saidexpandable portions may have different surface structures and/or crosssections.

The radially expandable portion may e.g. be realized or implemented bydesigning the penile implant with a waist so that the cross section ofthe penile implant comprises two concavenesses or indentations which maybe located substantially opposite each other. The implant, and hencealso the cross section of the implant, may also comprise more than twoconcavenesses or indentations, e.g. four concavenesses or indentations,which may be located substantially equally spaced around thecircumference of the implant. The penile implant may also comprise oneconcaveness or indentation where it is suitable that the penile implantis placed in the corpus cavernosum so that the opening of theconcaveness or indentation faces, or substantially faces, the urethra.The at least one concaveness or indentation may e.g. be substantiallyU-shaped or V-shaped in cross section and suitably has a rounded shapewithout sharp edges. Hence, the radial bellows structure comprises thementioned waist and/or concaveness(es) or indentation(s).

The longitudinally expandable portion may comprise a longitudinalbellows structure having a substantially saw tooth shaped surface. Theridges and grooves of the longitudinal bellows structure also may have asubstantially square shape so that the longitudinal bellows structurecomprises a square wave shaped surface. The ridges and grooves of thelongitudinal bellows structure may also be rounded to different degreesso that the longitudinal bellows structure comprises a more or less waveshaped surface. The surface shape(s) of the longitudinally expandableportion may extend along a part of, parts of, or the complete,circumference of the implant. In the case of a surface shape comprisingridges and grooves, it is suitable that the ridges and grooves extend ina substantially circumferential direction of the penile implant and thatthe ridges and grooves are placed alternating one after the other in asubstantially longitudinal direction of the implant.

In general, both the radially expandable portion and the longitudinallyexpandable portion may comprise any suitable surface shape which enablesan appropriate function of the section(s), e.g. any of the surfaceshapes or elements described in the section of this applicationregarding the surface structure having elevated and lowered areas.

The radially expandable portion is suitably located on the part of thepenile implant that is adapted to be placed in the protruding orpendulous part of the penis. The longitudinally expandable portion maybe located on the part of the penile implant that is adapted to beplaced in the part of the penis that substantially extends on the insideof the body, also called the mot of the penis, and/or on the part of thepenile implant that is adapted to be placed in the protruding orpendulous part of the penis. The penile implant may suitably comprise arelatively short proximal portion and a flexible relatively long distalportion. Suitably the proximal portion is to be anchored or located inthe root of the penis and the distal portion is to be located in or toextend along the pendulous part of the penis. The radially and thelongitudinally expandable portion may also be located to partly overlapeach other. Both sections may e.g. be located on the distal portion, thelongitudinally expandable portion suitably on the part of the distalportion which is in the vicinity of the position where the proximal anddistal portion meet, and the radially expandable portion suitably extendalong substantially the whole distal portion. Depending on the desiredshape of the penis when the penile implant is in an expanded state theradially expandable portion may also extend along only a part of thedistal portion. The part of the penile implant that is adapted to beplaced in the vicinity of or at the position of the glans penis may e.g.have no radially expandable portion or a radially expandable portionwith smaller or greater possible radial expansion than the rest of theradially expandable portion.

The longitudinal extension of the longitudinally expandable portion whenthe penile implant is in its collapsed state is suitably in the intervalof around 5-100 mm, depending on the circumstances, e.g. the desiredpossible prolongation or extension when the penile implant is expandedand the length of the penile implant in its collapsed state. It may besuitable that the longitudinally expandable portion has a longitudinalextension that is around 10 to 40 percent of the total longitudinalextension of the penile implant. The depth of the bellows structure ofthe longitudinally expandable portion when the penile implant is in itscollapsed state is suitably in the interval of around 0.5 to 5 mm, evenmore suitable around 1-4 mm and most suitably around 1.5-3 mm, dependingon the circumstances, e.g. the desired possible prolongation orextension when the penile implant is expanded and the length of thepenile implant. For measuring the depth of a bellows structure one maymeasure the distance between the bottom of a groove and the top of aridge.

The longitudinal extension of the radially expandable portion has beendiscussed above. When the penile implant is in its collapsed state asuitable interval for the longitudinal extension of the radiallyexpandable portion is around 5-250 mm, depending on the circumstances,e.g. the length of the distal part of the penile implant in itscollapsed state. It may be suitable that the radially expandable portionhas a longitudinal extension that is around 80 to 100 percent of thetotal longitudinal extension of the distal part of the penile implant.The total depth or extension of the concavenesses or indentations of theradially expandable portion when the penile implant is in its collapsedstate is suitably in the interval of around 5 to 70 mm, depending on thecircumstances, e.g. the desired diameter of the penile implant in thecollapsed state and in an expanded state. It may be suitable that thetotal depth or extension of the concavenesses or indentations of theradially expandable portion is around 40 to 60 percent of thecircumference of the penile implant in it collapsed state when notincluding the extension of the concavenesses or indentations whencalculating the circumference.

According to yet another aspect of the invention there is provided animplantable vibration device adapted to improve or remedy dysfunctionalejaculation. Suitably the vibration device is adapted to be implanted inthe genital area, e.g. in the corpus cavernosum of a penis of a personor in a penile implant for curing erectile impotence or in a penileprosthesis system for curing erectile impotence. The vibration device islocated so as to cause a vibration to improve or remedy dysfunctionalejaculation.

The vibration device may fully or partly remedy dysfunctionalejaculation. If the vibration device is located in a penile implant orpenile prosthesis system for curing erectile impotence, which is filledwith a transportable medium, e.g. a fluid, the vibration device may beplaced in the transportable medium. In this way the vibrations from thevibration device can be conveyed from the vibration device to the penileimplant or penile prosthesis system via the transportable medium. Inthis case the vibration device may be placed either in the penileimplant or in an element containing transportable medium and beingconnected to the penile implant. Such an element may e.g. be areservoir, a conduit or a pump. Hence, there is also provided a penileimplant and a penile prosthesis system comprising a vibration device.Generally the vibration device is adapted and located so as to stimulateat least a part of the sexually responsive tissue of the penis of thepatient or person.

The vibration device may be of any suitable known type, e.g. a motorhaving an eccentric element eccentrically mounted to its axis, avibration device of the magnetic type using magnetic repulsion and/orattraction, a piezoelectric device or a vibration device having areciprocating piston. Suitably the vibration device is adapted to createmovement with a frequency of around 0.1 to 10 000 Hz, and to createmovement with an amplitude of around 0.01 to 30 mm.

Suitably the penile implant or implantable device comprises at least onehollow section or hollow body in all of the described aspects. The atleast one hollow section or hollow body may be expandable and/orcollapsible and may extend along the whole length, or part of thelength, of the implantable device.

The implantable device may also comprise a transportable medium adaptedto be received into the at least one hollow section or hollow body, orto be withdrawn from the at least one hollow section or hollow body, inorder to activate respectively inactivate the implantable device.

The at least one hollow section or hollow body may suitably be adaptedto receive the transportable medium, and adapted so that thetransportable medium can be withdrawn from the hollow section or hollowbody, in order to activate respectively inactivate the implantabledevice.

The implantable device may be placed in the corpus cavernosum by anysuitable known technique, e.g. by surgically forming a passageway in thecorpus cavernosum and then placing or locating the implantable device inthe passageway.

According to yet a further aspect of the invention there is provided apenile prosthesis system for curing erectile impotence where the systemcomprises at least one penile implant or penile implantable device asdescribed herein. Suitably the system comprises two penile implants orpenile implantable devices. Such a system suitably includes an operationdevice connected, suitably by a conduit, to the at least one penileimplantable device. The operation device may comprise a fluid reservoirand a pump both connected to the at least one penile implantable deviceby a conduit so that fluid can be pumped to and from the penileimplantable device(s). The pump may be manually operated or powered byan energy source. The system may as well comprise a control deviceconnected to the operation device, suitably to the pump but it may aswell be connected to the fluid reservoir. The control device maytransmit control signals and/or powering signals to the pump and/or thefluid reservoir.

In the text describing the system, e.g. a penile prosthesis system, itis stated that different parts is or are for operating or regulating thepenile implant or penile implantable device. This implies e.g. thatthese different part are adapted to fill and pressurize the penileimplantable device and mentioned part of the penile implantable devicewith a transportable medium, e.g. a fluid. This implies e.g. also thatthese different part are adapted to withdraw a transportable medium,e.g. a fluid, from the penile implantable device and mentioned parts ofthe penile implantable device. Mentioned parts of the penile implantabledevice are e.g. the expandable section, the pre-formed section, thebending portion, the radially expandable portion, the longitudinallyexpandable portion, the first and second compartments, the first andsecond hollow portions and the hollow body.

According to yet another aspect of the invention there is provided amethod for invasively placing said penile implantable device in thecorpus cavernosum of a penis.

As mentioned, said penile implantable device may suitably be a penileimplant or penile prosthesis for curing erectile impotence and adaptedto be implanted in the corpus cavernosum of a penis.

The described aspects and features may be freely combined with anotherand thereby an implantable device or implantable vibration device havingadvantages from the combined aspects and features can be achieved. Bycombining the described aspects and features additional, synergisticeffects can also be achieved. The described surface structure in itsdifferent embodiments may e.g. be used in any of the other aspects ofthe invention whereby additional advantages can be obtained. For examplemay the pre-formed section, the bending portion and the radially andlongitudinally expandable portions comprise any of the elements,features and embodiments of the surface structure. Further may forexample a penile implant comprise a pre-formed section and/or a bendingportion and/or a radially and a longitudinally expandable portion. Theimplantable vibration device may as well be combined with theimplantable device and the organ or penile prosthesis system.

The invention may also be described as in the following.According to one aspect there is provided an implantable device. Theimplantable device may be adapted to post-operatively be adjustable andmay comprise at least one expandable section. The implantable device maybe adapted to be adjustable between a first collapsed state, in whichthe expandable section is collapsed, and a second expanded state, inwhich the expandable section is expanded.

-   -   The outer surface of said expandable section may at least partly        comprise a surface structure having elevated areas alternating        with lowered areas.    -   Said expandable section may be adapted to have, in at least one        of said first collapsed and second expanded states, a first        distance between adjacent elevated areas which distance is        sufficiently extended to prevent growth of fibrotic tissue from        directly interconnecting adjacent elevated areas to an extent        that compromises the adjustability between a first collapsed and        a second expanded state of said implantable device.    -   The surface structure may further comprise connecting areas        between adjacent elevated and lowered areas. The connecting        areas may further be adapted to have, in at least one of said        first collapsed and second expanded states,    -   a second distance between adjacent connecting areas which        distance is sufficiently extended to prevent growth of fibrotic        tissue from directly interconnecting adjacent connecting areas        to an extent that compromises the adjustability between a first        collapsed and a second expanded state of said implantable        device.

The implantable device may optionally have the following furthercharacteristics:

-   -   According to one embodiment there is provided an implantable        device which is adapted to be non-invasively adjustable.    -   According to another embodiment there is provided an implantable        device wherein at least said expandable section, is hollow or        comprises a hollow body.    -   According to a further embodiment there is provided an        implantable device wherein said implantable device is        substantially completely hollow or comprises a hollow body        extending along substantially the complete length of said        implantable device.    -   According to yet another embodiment there is provided an        implantable device wherein said implantable device comprises a        transportable medium, e.g. a fluid. The transportable medium may        be adapted to be received into and pressurize said expandable        section and/or said implantable device and/or said hollow body,        to bring said implantable device into said second expanded        state. The transportable medium may further be adapted to be        withdrawn from said expandable section and/or said implantable        device and/or said hollow body, to bring said implantable device        into said first collapsed state.    -   According to yet a further embodiment there is provided an        implantable device wherein said expandable section and/or said        implantable device and/or said hollow body, is adapted to        receive, and be pressurized by, a fluid to bring said        implantable device (10) into said second expanded state. Further        may said expandable section and/or said implantable device        and/or said hollow body be adapted to release said fluid, or        adapted so that said fluid may be withdrawn therefrom, to bring        said implantable device into said first collapsed state.    -   According to one embodiment there is provided an implantable        device wherein said first respectively said second distance is        adapted to fulfil said condition of preventing fibrotic tissue        from directly connecting adjacent areas when said implantable        device is in its first collapsed state.    -   According to another embodiment there is provided an implantable        device wherein said first respectively said second distance is        adapted to fulfil said condition of preventing fibrotic tissue        from directly connecting adjacent areas, when said implantable        device is in its second expanded state.    -   According to a further embodiment there is provided an        implantable device wherein the outer surface of said expandable        section is at least partly substantially bellows shaped or        substantially corrugated.    -   According to yet another embodiment there is provided an        implantable device wherein said implantable device, seen in        cross section, comprises a waist portion.        According to yet a further embodiment there is provided an        implantable device wherein the lowered areas lie in a plane        substantially in parallel to a plane of the elevated areas.    -   According to one embodiment there is provided an implantable        device wherein the outer surface of said expandable section at        least partly comprises ridges and grooves.    -   According to another embodiment there is provided an implantable        device wherein said ridges and grooves are substantially        parallel.    -   According to a further embodiment there is provided an        implantable device wherein the outer surface of said expandable        section at least partly comprises protrusions and depressions.    -   According to yet another embodiment there is provided an        implantable device wherein the top surfaces of the ridges and/or        the bottom surfaces of the grooves at least partly have an        extension greater than 1 mm in a direction transversal to the        longitudinal direction of the ridges and/or grooves.    -   According to yet a further embodiment there is provided an        implantable device wherein the distance between a plane of an        elevated area and a plane of a lowered area is larger than 1 mm        to facilitate achieving said first collapsed and/or said second        expanded state.    -   According to one embodiment there is provided an implantable        device wherein said expandable section is preformed into a shape        substantially corresponding to the shape assumed by said        implantable device in its first collapsed state.    -   According to another embodiment there is provided an implantable        device wherein said alternating elevated areas and lowered areas        are distributed over said outside surface of said implantable        device so as to facilitate said implantable device assuming a        specific shape when expanded.    -   According to a further embodiment there is provided an        implantable device wherein said alternating elevated areas and        lowered areas cover a larger part of one side of said        implantable device, than of the opposite side of said        implantable device.    -   According to another aspect there is provided an implantable        device. Further may said implantable device be adapted to be        post-operatively adjustable. Said implantable device may        comprise a pre-formed section which is positioned at a point or        in an area of said implantable device which is in the vicinity        of and/or includes the position where a bent part of an organ        is. Said preformed section is formed in such a way that bending        creases are avoided or reduced when said implantable device is        implanted and the organ is in a relaxed or flaccid position.    -   The implantable device may optionally have the following further        characteristics:    -   According to one embodiment there is provided an implantable        device wherein said pre-formed section comprises at least one        fold, pleat, bellow shaped part or part having a smooth surface,        or combinations thereof. Said pre-formed section may have a        longitudinal extension in the interval of around 1 to 100 mm.    -   According to another embodiment there is provided an implantable        device wherein said pre-formed section is expandable.    -   According to a further embodiment there is provided an        implantable device which is adapted to be non-invasively        adjustable.    -   According to yet another embodiment there is provided an        implantable device wherein said implantable device is adapted to        selectively assume a first in-activated state, in which said        implantable device may be collapsed, and a second activated        state, in which said implantable device may be expanded.    -   According to yet a further embodiment there is provided an        implantable device wherein at least said pre-formed section is        hollow or comprises a hollow body.    -   According to one embodiment there is provided an implantable        device wherein said implantable device is substantially        completely hollow or comprises a hollow body extending along        substantially the complete length of said implantable device.    -   According to another embodiment there is provided an implantable        device which may comprise a transportable medium, e.g. a fluid.        The transportable medium is adapted to be received into and        pressurize said pre-formed section and/or said implantable        device and/or said hollow body, to bring said implantable device        into said second activated state. The transportable medium may        as well be adapted to be withdrawn from said pre-formed section        and/or said implantable device and/or said hollow body, to bring        said implantable device into said first in-activated state.    -   According to a further embodiment there is provided an        implantable device wherein said pre-formed section and/or said        implantable device and/or said hollow body, is adapted to        receive, and be pressurized by, a fluid to bring said        implantable device (10) into said second activated state.        Further said pre-formed section and/or said implantable device        and/or said hollow body may be adapted to release said fluid, or        adapted so that said fluid may be withdrawn therefrom, to bring        said implantable device into said first in-activated state.    -   According to a further aspect there is provided an implantable        device. Further may said implantable device be adapted to be        post-operatively adjustable and to be implanted in an organ.    -   Said implantable device may as well be adapted to selectively        assume an in-activated state whereby said organ can be made        flaccid, and an activated state whereby said organ can be        erected or made erected.    -   Said implantable device may be collapsed in its in-activated        state and expanded in its activated state.    -   Said implantable device may have a relatively short proximal        portion which is suited to be placed or located in the root of        the organ, and a flexible relatively long distal portion, which        is suited to be placed so as to extend along or to be located in        the pendulous or protruding part of the organ.    -   Said implantable device may further comprise a bending portion        placed or located between the proximal and the distal portion,        or in the vicinity of the position where the proximal and the        distal portion meet.    -   Said bending portion may be adapted to enable said implantable        device, when said implantable device is implanted and activated,        to bring at least the pendulous or protruding portion of the        organ to a position in which the organ has an acute angle with        the vertical plane when said person is standing. That is, a        position in which at least the pendulous or protruding portion        of the organ is upwardly bent when said person is standing.

The implantable device may optionally have the following furthercharacteristics:

-   -   According to one embodiment there is provided an implantable        device wherein said bending portion may comprise a pliable or        elastic wall part of said implantable device. Said wall part        extends along a part of, along parts of, or along the complete,        circumference of said implantable device. Said wall part extends        in such a way as to, when said implantable device is implanted        and activated, bring at least the pendulous part of the organ to        a position in which the organ has an acute angle with the        vertical plane when said person is standing.    -   According to another embodiment there is provided an implantable        device wherein said wall part extends along at least a part of        the underside, and along at least a part of the upper side of        said implantable device. Said wall part has a greater        longitudinal extension on the underside than on the upper side        of said implantable device (10), when said implantable device        (10) is activated and/or inactivated. This in order to, when        said implantable device is implanted and activated, bring at        least the pendulous part of the organ to a position in which the        organ has an acute angle with the vertical plane when said        person is standing.    -   According to a further embodiment there is provided an        implantable device wherein said bending portion comprises a        bellows structure which extends along a part of, along parts of,        or along the complete, circumference of said implantable device.        Said bellows structure is designed so that at least part of the        underside of said implantable device shows a greater length        expansion when said implantable device is activated than the        upper side of said implantable device. This in order to, to,        when said implantable device is implanted and activated, bring        at least the pendulous part of the organ to a position in which        the organ has an acute angle with the vertical plane when said        person is standing.    -   According to yet another embodiment there is provided an        implantable device wherein said bellows structure extends along        at least a part of the underside, and along at least a part of        the upper side of said implantable device.    -   Said bellows structure may have a greater longitudinal extension        on the underside than on the upper side of said implantable        device. Further may said bellows structure have a greater depth,        at least when said implantable device is in its in- or        non-activated state, on the underside than on the upper side of        said implantable device.    -   This in order to, when said implantable device is implanted and        activated, bring at least the pendulous part of the organ to a        position in which the organ has an acute angle with the vertical        plane when said person is standing.    -   According to one embodiment there is provided an implantable        device wherein said bending portion is positioned at a point or        in an area of said implantable device which is in the vicinity        of and/or including the position where the pendulous or        protruding part of the organ starts.    -   According to another embodiment there is provided an implantable        device wherein said bending portion is positioned at or on said        proximal portion, suitably in the vicinity of the position where        said proximal portion and said distal portion meet. According to        a further embodiment there is provided an implantable device        which is adapted to be non-invasively adjustable.    -   According to yet another embodiment there is provided an        implantable device wherein at least said bending portion is        hollow or comprises a hollow body.    -   According to yet a further embodiment there is provided an        implantable device which is substantially completely hollow or        comprises a hollow body extending along substantially the        complete length of said implantable device.    -   According to one embodiment there is provided an implantable        device which comprises a transportable medium, e.g. a fluid.        Said transportable medium is adapted to be received into and        pressurize said bending portion and/or said implantable device        and/or said hollow body in order to bring said implantable        device into said second activated state. Said transportable        medium may as well be adapted to be withdrawn from said bending        portion and/or said implantable device and/or said hollow body,        to bring said implantable device into said first in-activated        state.    -   According to another embodiment there is provided an implantable        device wherein said bending portion and/or said implantable        device and/or said hollow body, is adapted to receive, and be        pressurized by, a fluid to bring said implantable device into        said second activated state. Further may said bending portion        and/or said implantable device and/or said hollow body be        adapted to release said fluid, or adapted so that said fluid may        be withdrawn therefrom, to bring said implantable device into        said first in-activated state.    -   According to a further embodiment there is provided an        implantable device wherein said bending portion comprises that        said proximal portion has a pliable top wall and a pliable        bottom wall. Said bottom wall is designed to longitudinally        distend more than said top wall, when said implantable device is        brought into said second activated state by said transportable        medium. This in order to cause said distal portion to bend        upwardly in relation to said proximal portion.    -   According to yet another embodiment there is provided an        implantable device wherein said bottom wall of said proximal        portion forms circumferentially extending alternating ridges and        grooves. Said bottom wall thereby behaves like an expanding        bellows when said implantable device is brought into said second        activated state by said transportable medium.    -   According to yet a further embodiment there is provided an        implantable device wherein said ridges of said bottom wall are        spaced apart from one another, when said implantable device is        in its inactivated state.    -   According to one embodiment there is provided an implantable        device wherein said top wall forms circumferentially extending        alternating ridges and grooves. These ridges and grooves are        dimensioned such that said top wall longitudinally distends less        than said bottom wall, when said implantable device is brought        into said second activated state by said transportable medium    -   According to another embodiment there is provided an implantable        device wherein said grooves are wedge-shaped.    -   According to a further embodiment there is provided an        implantable device wherein said ridges have a polygonal        cross-section.    -   According to yet another embodiment there is provided an        implantable device wherein said distal portion of said        implantable device comprises circumferentially extending        alternating ridges and grooves. Thereby said distal portion        behaves like an expanding bellows and longitudinally prolongs,        when said implantable device is brought into said second        activated state by said transportable medium.    -   According to yet a further embodiment there is provided an        implantable device wherein said proximal portion of said        implantable device is made of an elastic material.    -   According to one embodiment there is provided an implantable        device wherein said top wall of said proximal portion is        substantially thicker than said bottom wall of said proximal        portion.    -   According to a further embodiment there is provided an        implantable device wherein said elastic material comprises        silicone elastomer.    -   According to yet another aspect there is provided an implantable        device. Said implantable device may be adapted to be implanted        in the of a organ of a person. Said implantable device is at        least partly hollow and/or at least partly comprises a hollow        body. Said implantable device comprises a foam material        transparent for fluid, said foam material is at least partly        filling said implantable device and/or said hollow body.    -   Suitably said foam material has a lower density than water. Said        implantable device and/or said hollow body is adapted to be        filled with said foam material and said fluid so that said foam        material and said fluid together substantially fill the volume        of said implantable device and/or said hollow body.

The implantable device may optionally have the following furthercharacteristics.

-   -   According to one embodiment there is provided an implantable        device wherein said foam material comprises open spaces that can        be filled with said fluid.    -   According to another embodiment there is provided an implantable        device wherein said foam material is a closed cellular foam        material which comprises closed spaces, suitably bubbles. The        closed spaces may contain, or may be filled with, a solid        material, a gas or a fluid, e.g. air or foam material.    -   According to a further embodiment there is provided an        implantable device wherein said implantable device is adapted to        be non-invasively adjustable.    -   According to yet another embodiment there is provided an        implantable device, which is adapted to selectively assume a        first in-activated state, wherein said implantable device may be        collapsed, and a second activated state, wherein said        implantable device may be expanded.    -   According to yet a further embodiment there is provided an        implantable device wherein said fluid is adapted to be received        into and pressurize said implantable device and/or said hollow        body, to bring said implantable device into said second        activated state. Said fluid may also be adapted to be withdrawn        from said implantable device and/or said hollow body, to bring        said implantable device into said first in-activated state.    -   According to one embodiment there is provided an implantable        device wherein said implantable device and/or said hollow body,        is adapted to receive, and be pressurized by, a fluid to bring        said implantable device (10) into said second activated state.        Said implantable device and/or said hollow body may also be        adapted to release said fluid, or adapted so that said fluid may        be withdrawn, to bring said implantable device into said first        in-activated state.    -   According to yet a further aspect there is provided an        implantable device, which may be an implantable device for        curing erectile impotence. Said implantable device may be        elongated and may be adapted to be implanted in the of a organ        of a person. Said implantable device may also be adapted to        post-operatively be adjustable.    -   Said implantable device may comprise at least one expandable        portion and is adjustable between a first collapsed state and at        least one other, partly or fully expanded, state. In the        collapsed state the at least one expandable portion is        collapsed, and in the other, partly or fully expanded, state        said at least one expandable portion is partly or fully        expanded.    -   Said at least one expandable portion may comprise at least one        item chosen from the group consisting of; a radially expandable        portion, a radially expandable segment, a longitudinally        expandable portion, and a longitudinally expandable segment.    -   Said implantable device may have a predetermined shape with a        length and a diameter and may be adapted to allow an increase of        the implantable device diameter and/or length when being        adjusted from said first collapsed to said at least one partly        or fully expanded state. This in order to achieve increased        organ size when said implantable device is implanted and partly        or fully expanded, as compared to a relaxed status of the organ.    -   According to yet another aspect there is provided an implantable        device, which may be an implantable device for curing erectile        impotence. Said implantable device may be elongated and may be        adapted to be implanted in the of a organ of a person. Said        implantable device may be adapted to post-operatively be        adjustable.    -   Said implantable device may comprise at least one expandable        portion and may be adjustable between a first in-activated or        collapsed state and at least one other, partly or fully        expanded, activated state. In the first state said at least one        expandable portion is collapsed and in the other, activated        state, said at least one expandable portion is partly or fully        expanded.    -   Said at least one expandable portion may comprise a radially        expandable portion and/or a radially expandable segment at least        partly comprising a cross section presenting at least one        concaveness or indentation. Said cross section may present a        concaveness or indentation facing the urethra of the organ.    -   Said implantable device may have a predetermined shape with a        length and a diameter and may be adapted to allow an increase of        the implantable device diameter when being adjusted from said        first in-activated or collapsed state to said at least one        other, partly or fully expanded, activated state. This in order        to achieve increased organ size when said implantable device is        implanted and partly or fully expanded, as compared to a relaxed        status of the organ.    -   The implantable device may optionally have the following further        characteristics.    -   According to one embodiment there is provided an implantable        device wherein said radially expandable portion or said radially        expandable segment at least partly comprises a cross section        presenting at least one concaveness or indentation.    -   According to another embodiment there is provided an implantable        device wherein said cross section presents at least two        concavenesses or indentations.    -   According to a further embodiment there is provided an        implantable device wherein said cross section presents a        concaveness or indentation facing the urethra.    -   According to yet another embodiment there is provided an        implantable device which comprises said radially expandable        portion or said radially expandable segment on the part of said        implantable device that is adapted to be placed in the        protruding or pendulous part of the organ.    -   According to yet a further embodiment there is provided an        implantable device wherein said at least one expandable portion        comprises a longitudinally expandable portion or a        longitudinally expandable segment. The longitudinally expandable        portion or the longitudinally expandable segment may comprise a        longitudinally expandable structure that comprises at least one        concaveness or indentation.    -   According to one embodiment there is provided an implantable        device wherein said at least one expandable portion comprises a        longitudinally expandable portion or a longitudinally expandable        segment. The longitudinally expandable portion or the        longitudinally expandable segment may comprise a longitudinal        bellows structure that comprises ridges and grooves that extend        substantially circumferentially along a part of, along parts of,        or along the complete, circumference of said implantable device.    -   According to another embodiment there is provided an implantable        device wherein said longitudinally expandable portion or said        longitudinally expandable segment is present on a proximal part        of said implantable device. The proximal part may be adapted to        be placed in the root part of the organ. The root part of the        organ extends substantially on the inside of the body.    -   According to a further embodiment there is provided an        implantable device wherein said longitudinally expandable        portion or said longitudinally expandable segment is present on        a distal part of said implantable device. Said distal part in        suitably adapted to be placed in the protruding or pendulous        part of the organ.    -   According to one embodiment there is provided an implantable        device wherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is sufficiently extended to prevent growth of fibrotic tissue fromdirectly interconnecting said substantially opposing sides to an extentthat compromises the adjustability between a first collapsed state andat least one other, partly or fully expanded, state.

-   -   According to another embodiment there is provided an implantable        device wherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is greater than around 1 mm, greater than around 2 mm, or greater thanaround 3 mm.

-   -   According to yet another embodiment there is provided an        implantable device which is adapted to be non-invasively        adjustable.    -   According to a further embodiment there is provided an        implantable device wherein at least said at least one expandable        portion is hollow or comprises a hollow body.    -   According to yet a further embodiment there is provided an        implantable device wherein said implantable device is        substantially completely hollow or comprises a hollow body        extending along substantially the complete length of said        implantable device.    -   According to one embodiment there is provided an implantable        device wherein said implantable device comprises a transportable        medium, e.g. a fluid. The transportable medium may be adapted to        be received into and pressurize said at least one expandable        portion and/or said implantable device and/or said hollow body.        This in order to bring said implantable device into said at        least one partly or fully expanded state. The transportable        medium may also be adapted to be withdrawn from said at least        one expandable portion and/or said implantable device and/or        said hollow body, to bring said implantable device (10) into        said first collapsed state.        According to another embodiment there is provided an implantable        device wherein said at least one expandable portion and/or said        implantable device and/or said hollow body, is adapted to        receive, and to be pressurized by, a fluid. This in order to        bring said implantable device into said at least one partly or        fully expanded state. Said at least one expandable portion        and/or said implantable device and/or said hollow body may also        be adapted to release said fluid, or adapted so that said fluid        may be withdrawn, to bring said implantable device into said        first collapsed state.    -   According to a further embodiment there is provided an        implantable device wherein said implantable device or said        hollow body comprises a first and at least one second        compartment both being adapted to be filled and pressurized with        a fluid. The first and the at least one second compartment are        separated by at least one dividing wall having at least one        valve.    -   Said radially expandable segment and said longitudinally        expandable segment may each comprise at least one of a second        compartment, a dividing wall having at least one valve, at least        one invagination.    -   Said at least one second compartment comprises at least one        invagination. Said at least one valve suitably has a first side        or face which is adapted to be closed for fluid up to a        predetermined fluid pressure threshold. For fluid pressures        above said fluid pressure threshold said at least one valve is        adapted to open. Said at least one valve suitably also has a        second side or face which is adapted to be open for fluid at        substantially any pressure, at least for a pressure greater than        zero.    -   Said at least one invagination is adapted to bulge when        subjected to fluid pressure and to resume its invaginated form        when said fluid pressure is removed.    -   According to yet a further embodiment there is provided an        implantable device wherein said first compartment is adapted to        be connected to a source of pressurized fluid.    -   Said first side or face of said at least one valve is suitably        facing said first compartment and said second side or face of        said at least one valve is suitably facing said at least one        second compartment. This is in order to enable that said at        least one second compartment can be filled and pressurized with        fluid when the fluid pressure in said first compartment exceeds        said fluid pressure threshold so that said at least one        invagination bulges and hence prolongs or radially expands said        implantable device and/or hollow body.    -   According to yet another embodiment there is provided an        implantable device wherein said implantable device or said        hollow body comprises a longitudinally expandable portion having        a first and a second hollow portion. The first and the second        hollow portion are each adapted to be filled and pressurized        with a fluid, they may be connected by an elastic first conduit,        and optionally also by an elastic second conduit. The first and        the second hollow portion may as well be connected by an elastic        connecting portion    -   At least one of, and suitably each of, said first and second        hollow portions comprises at least one invagination. Said        invagination is suitably adapted to bulge when subjected to        fluid pressure and to resume its invaginated form when said        fluid pressure is removed.    -   According to one embodiment there is provided an implantable        device wherein each of said first and second hollow portions        comprises an invagination. Said invaginations are suitably        facing each other and are adapted to bulge and mutually exert a        force on each other when subjected to fluid pressure. This in        order to prolong said implantable device and/or hollow body when        said first and second hollow portions are filled and pressurized        with a fluid. Said invaginations are suitably adapted to resume        their invaginated form when said fluid pressure is removed so        that said implantable device and/or hollow body resumes its not        prolonged length.        In another aspect there is provided a surgery method where an        implantable device as described above is implanted in the        patient.        In a further aspect there is provided a system that comprises an        implantable device as described above.        In one embodiment the system comprises at least one switch        implantable in the patient for manually and non-invasively        controlling the implantable device.        In one embodiment the system comprises a hydraulic device having        an implantable hydraulic reservoir, which is hydraulically        connected to the implantable device, wherein the implantable        device is adapted to be non-invasively regulated by manually        pressing the hydraulic reservoir.        In one embodiment the system comprises a wireless remote control        for non-invasively controlling the implantable device. The        wireless remote control may comprise at least one external        signal transmitter and/or receiver, further comprising an        internal signal receiver and/or transmitter implantable in the        patient for receiving signals transmitted by the external signal        transmitter or transmitting signals to the external signal        receiver.        In one embodiment the wireless remote control transmit at least        one wireless control signal for controlling the implantable        device.        In one embodiment the wireless control signal comprises a        frequency, amplitude, or phase modulated signal or a combination        thereof.        In one embodiment the wireless remote control transmit an        electromagnetic carrier wave signal for carrying the control        signal.        One embodiment comprises a wireless energy transmission device        for non-invasively energizing implantable energy consuming        components of the implantable device with wireless energy.        In one embodiment there is provided a wave signal selected from        the following: a sound wave signal, an ultrasound wave signal,        an electromagnetic wave signal, an infrared light signal, a        visible light signal, an ultra violet light signal, a laser        light signal, a micro wave signal, a radio wave signal, an x-ray        radiation signal and a gamma radiation signal. The signal may be        an analogue signal, a digital signal, or a combination of an        analogue and digital signal        The wireless energy may be different in different embodiments,        for example: an electric field, a magnetic field, or a combined        electric and magnetic field.        The control signal may be different in different embodiments,        for example an electric field, a magnetic field, or a combined        electric and magnetic field.        In another embodiment there is provided an implantable internal        energy source for powering implantable energy consuming        components of the implantable device.        In one embodiment there is provided an external energy source        for transferring energy in a wireless mode, wherein the internal        energy source is chargeable by the energy transferred in the        wireless mode.        In one embodiment there is provided a sensor or measuring device        sensing or measuring a functional parameter correlated to the        transfer of energy for charging the internal energy source, and        a feedback device for sending feedback information from inside        the patients body to the outside thereof, the feedback        information being related to the functional parameter sensed by        the sensor or measured by the measuring device.        One embodiment further comprises a feedback device for sending        feedback information from inside the patient's body to the        outside thereof, the feedback information being related to at        least one of a physical parameter of the patient and a        functional parameter related to the implantable device.        In one embodiment there is provided a sensor and/or a measuring        device and an implantable internal control unit for controlling        the implantable device in response to information being related        to at least one of a physical parameter of the patient sensed by        the sensor or measured by the measuring device and a functional        parameter related to the implantable device sensed by the sensor        or measured by the measuring device. The physical parameter may        be a pressure or a motility movement.        In one embodiment there is provided an external data        communicator and an implantable internal data communicator        communicating with the external data communicator, wherein the        internal communicator feeds data related to the implantable        device or the patient to the external data communicator and/or        the external data communicator feeds data to the internal data        communicator.        In one embodiment there is provided a motor or a pump for        operating the implantable device.        In one embodiment there is provided a hydraulic operation device        for operating the implantable device.        In one embodiment there is provided an operation device for        operating the implantable device, wherein the operation device        comprises a servo designed to decrease the force needed for the        operation device to operate the implantable device instead the        operation device acting a longer way, increasing the time for a        determined action.        In one embodiment there is provided a operation device for        operating the implantable device, wherein the wireless energy is        used in its wireless state to directly power the operation        device to create kinetic energy for the operation of the        implantable device, as the wireless energy is being transmitted        by the energy-transmission device.        In one embodiment there is provided an energy-transforming        device for transforming the wireless energy transmitted by the        energy-transmission device from a first form into a second form        energy.        In one embodiment the energy-transforming device directly powers        implantable energy consuming components of the implantable        device with the second form energy, as the energy-transforming        device transforms the first form energy transmitted by the        energy-transmission device into the second form energy.        In one embodiment the second form energy comprises at least one        of a direct current, pulsating direct current and an alternating        current.        In one embodiment there is provided an implantable accumulator,        wherein the second form energy is used at least partly to charge        the accumulator.        In one embodiment the energy of the first or second form        comprises at least one of magnetic energy, kinetic energy, sound        energy, chemical energy, radiant energy, electromagnetic energy,        photo energy, nuclear energy thermal energy, nonmagnetic energy,        non-kinetic energy, non-chemical energy, non-sonic energy,        non-nuclear energy and non-thermal energy.        In one embodiment there are provided implantable electrical        component including at least one voltage level guard and/or at        least one constant current guard.        In one embodiment there is provided a control device for        controlling the transmission of wireless energy from the        energy-transmission device, and an implantable internal energy        receiver for receiving the transmitted wireless energy, the        internal energy receiver being connected to implantable energy        consuming component of the implantable device for directly or        indirectly supplying received energy thereto, the system further        comprising a determination device adapted to determine an energy        balance between the energy received by the internal energy        receiver and the energy used for the implantable energy        consuming component of the implantable device, wherein the        control device controls the transmission of wireless energy from        the external energy-transmission device, based on the energy        balance determined by the determination device.        In one embodiment the determination device is adapted to detect        a change in the energy balance, and the control device controls        the transmission of wireless energy based on the detected energy        balance change.        In one embodiment the determination device is adapted to detect        a difference between energy received by the internal energy        receiver and energy used for the implantable energy consuming        component of the implantable device, and the control device        controls the transmission of wireless energy based on the        detected energy difference.        In one embodiment the energy-transmission device comprises a        coil placed externally to the human body, further comprising an        implantable energy receiver to be placed internally in the human        body and an electric circuit connected to power the external        coil with electrical pulses to transmit the wireless energy, the        electrical pulses having leading and trailing edges, the        electric circuit adapted to vary first time intervals between        successive leading and trailing edges and/or second time        intervals between successive trailing and leading edges of the        electrical pulses to vary the power of the transmitted wireless        energy, the energy receiver receiving the transmitted wireless        energy having a varied power.        In one embodiment the electric circuit is adapted to deliver the        electrical pulses to remain unchanged except varying the first        and/or second time intervals.        In one embodiment the electric circuit has a time constant and        is adapted to vary the first and second time intervals only in        the range of the first time constant, so that when the lengths        of the first and/or second time intervals are varied, the        transmitted power over the coil is varied.        In one embodiment there is provided a system comprising an        implantable internal energy receiver for receiving wireless        energy, the energy receiver having an internal first coil and a        first electronic circuit connected to the first coil, and an        external energy transmitter for transmitting wireless energy,        the energy transmitter having an external second coil and a        second electronic circuit connected to the second coil, wherein        the external second coil of the energy transmitter transmit        wireless energy which is received by the first coil of the        energy receiver, the system further comprising a power switch        for switching the connection of the internal first coil to the        first electronic circuit on and off, such that feedback        information related to the charging of the first coil is        received by the external energy transmitter in the form of an        impedance variation in the load of the external second coil,        when the power switch switches the connection of the internal        first coil to the first electronic circuit on and off.        In one embodiment there is a an implantable internal energy        receiver for receiving wireless energy, the energy receiver        having an internal first coil and a first electronic circuit        connected to the first coil, and an external energy transmitter        for transmitting wireless energy, the energy transmitter having        an external second coil and a second electronic circuit        connected to the second coil, wherein the external second coil        of the energy transmitter transmit wireless energy which is        received by the first coil of the energy receiver, the system        further comprising a feedback device for communicating out the        amount of energy received in the first coil as a feedback        information, and wherein the second electronic circuit includes        a determination device for receiving the feedback information        and for comparing the amount of transferred energy by the second        coil with the feedback information related to the amount of        energy received in the first coil to obtain the coupling factors        between the first and second coils.        In one embodiment the transmitted energy may be regulated        depending on the obtained coupling factor.        In one embodiment there is provided a system wherein the        external second coil is adapted to be moved in relation to the        internal first coil to establish the optimal placement of the        second coil, in which the coupling factor is maximized.        In one embodiment there is provided a system wherein the        external second coil is adapted to calibrate the amount of        transferred energy to achieve the feedback information in the        determination device, before the coupling factor is maximized.        In a yet further aspect there is provided an operation method        using an implantable device or system according to the above        further comprising the steps of a) creating an opening in the        skin or organ wall of the male patient, b) dissecting an one        area of the sexually responsive tissue, c) placing the        implantable device within said area, adapted to postoperatively        stimulate said sexually responsive tissue on patient command.        In one embodiment there is provided an operation method        comprising the step of placing an operation device and a power        source within the body.        In one embodiment the operation method comprises placing an        implantable device comprising placing an integrated unit        comprising the implantable device and an operation device in the        same integrated unit.        In one embodiment the operation method comprises placing a power        source comprising, placing an control unit and a rechargeable        battery remote from said sexually responsive tissue.        In one embodiment the operation method comprises controlling        said implantable device post-operatively and non-invasively from        outside the body.        In one embodiment the operation method comprises the step of        creating an opening in the skin or organ wall of the male        patient comprising, a) inserting a tube or needle into the        patients body, b) filling the tube or needle with a gas and        thereby expanding a cavity within the male patients body, c)        inserting at least two laparoscopic trocars into said cavity, d)        inserting at least one camera trough at least one laparoscopic        trocar, e) inserting at least one dissecting tool through at        least one laparoscopic trocar.        In one embodiment the implantable device is adapted to be        implanted in any, or each, of the of the organ of the male        patient.        In one embodiment the implantable device is adapted to be        implanted in the vicinity of, or in contact with, the glans        organ of the organ of the male patient.        According to one embodiment there is provided a system        comprising at least one implantable device. Said implantable        device may be adapted to bring an organ to an erected or        activated state, when said implantable device is implanted and        activated or expanded.    -   Said implantable device is suitably adapted to bring a organ to        a flaccid state, when said implantable device is implanted in        the organ and in-activated or collapsed.        According to one aspect there is provided a method of implanting        the implantable device in a person or patient.        According to a further aspect there is provided a method of        implanting the system in a person or patient.        In a preferred embodiment, the system comprises at least one        switch implantable in the patient for manually and        non-invasively controlling the implant.        In another preferred embodiment, the system comprises a wireless        remote control for non-invasively controlling the implant.        In a preferred embodiment, the system comprises a hydraulic        operation device for operating the implant.        In one embodiment, the system comprises comprising a motor or a        pump for operating the implant.        The implant or implantable device may be any adjustable implant        adapted to change shape and/or size. The implant or implantable        device may e.g. be an implant for treating urinal or anal        incontinence, win retention, obesity, reflux disease, an implant        for patients having a stoma, an implant for implanted drug        delivery, implantable potency treatment, a heart pump, an        implant for aneurysm treatment, drainage treatment, fertility        treatment, gastric cancer treatment, fluid lubrication methods.        The implant or implantable device may e.g. be a penile implant,        a breast implant, a volume filling device, a bone adjustment        implant, a heart pump, a vertical gastric band or an anal        incontinence restriction device.        According to one aspect there is provided a penile implant, in        particular a penile implant for curing erectile impotence. The        penile implant may be adapted to be implanted in the corpus        cavernosum of a penis, may be adapted to post-operatively be        adjustable and may comprise at least one expandable section. The        penile implant may be adapted to be adjustable between a first        collapsed state, in which the expandable section is collapsed,        and a second expanded state, in which the expandable section is        expanded.    -   The outer surface of said expandable section may at least partly        comprise a surface structure having elevated areas alternating        with lowered areas.    -   Said expandable section may be adapted to have, in at least one        of said first collapsed and second expanded states,    -   a first distance between adjacent elevated areas which distance        is sufficiently extended to prevent growth of fibrotic tissue        from directly interconnecting adjacent elevated areas to an        extent that compromises the adjustability between a first        collapsed and a second expanded state of said penile implant    -   The surface structure may further comprise connecting areas        between adjacent elevated and lowered areas. The connecting        areas may further be adapted to have, in at least one of said        first collapsed and second expanded states,    -   a second distance between adjacent connecting areas which        distance is sufficiently extended to prevent growth of fibrotic        tissue from directly interconnecting adjacent connecting areas        to an extent that compromises the adjustability between a first        collapsed and a second expanded state of said penile implant.        The penile implant may optionally have the following further        characteristics:    -   According to one embodiment there is provided a penile implant        which is adapted to be non-invasively adjustable.    -   According to another embodiment there is provided a penile        implant wherein at least said expandable section, is hollow or        comprises a hollow body.    -   According to a further embodiment there is provided a penile        implant wherein said penile implant is substantially completely        hollow or comprises a hollow body extending along substantially        the complete length of said penile implant.

According to yet another embodiment there is provided a penile implantwherein said penile implant comprises a transportable medium, e.g. afluid. The transportable medium may be adapted to be received into andpressurize said expandable section and/or said penile implant and/orsaid hollow body, to bring said penile implant into said second expandedstate. The transportable medium may further be adapted to be withdrawnfrom said expandable section and/or said penile implant and/or saidhollow body, to bring said penile implant into said first collapsedstate.

-   -   According to yet a further embodiment there is provided a penile        implant wherein said expandable section and/or said penile        implant and/or said hollow body, is adapted to receive, and be        pressurized by, a fluid to bring said penile implant (10) into        said second expanded state. Further may said expandable section        and/or said penile implant and/or said hollow body be adapted to        release said fluid, or adapted so that said fluid may be        withdrawn therefrom, to bring said penile implant into said        first collapsed state.    -   According to one embodiment there is provided a penile implant        wherein said first respectively said second distance is adapted        to fulfil said condition of preventing fibrotic tissue from        directly connecting adjacent areas when said penile implant is        in it first collapsed state.    -   According to another embodiment there is provided a penile        implant wherein said first respectively said second distance is        adapted to fulfil said condition of preventing fibrotic tissue        from directly connecting adjacent areas, when said penile        implant is in its second expanded state.    -   According to a further embodiment there is provided a penile        implant wherein the outer surface of said expandable section is        at least partly substantially bellows shaped or substantially        corrugated.    -   According to yet another embodiment there is provided a penile        implant wherein said penile implant, seen in cross section,        comprises a waist portion.        According to yet a further embodiment there is provided a penile        implant wherein the lowered areas lie in a plane substantially        in parallel to a plane of the elevated areas.    -   According to one embodiment there is provided a penile implant        wherein the outer surface of said expandable section at least        partly comprises ridges and grooves.    -   According to another embodiment there is provided a penile        implant wherein said ridges and grooves are substantially        parallel.    -   According to a further embodiment there is provided a penile        implant wherein the outer surface of said expandable section at        least partly comprises protrusions and depressions.    -   According to yet another embodiment there is provided a penile        implant wherein the top surfaces of the ridges and/or the bottom        surfaces of the grooves at least partly have an extension        greater than 1 mm in a direction transversal to the longitudinal        direction of the ridges and/or grooves.    -   According to yet a further embodiment there is provided a penile        implant wherein the distance between a plane of an elevated area        and a plane of a lowered area is larger than 1 mm to facilitate        achieving said first collapsed and/or said second expanded        state.    -   According to one embodiment there is provided a penile implant        wherein said expandable section is preformed into a shape        substantially corresponding to the shape assumed by said penile        implant in its first collapsed state.    -   According to another embodiment there is provided a penile        implant wherein said alternating elevated areas and lowered        areas are distributed over said outside surface of said penile        implant so as to facilitate said penile implant assuming a        specific shape when expanded.    -   According to a further embodiment there is provided a penile        implant wherein said alternating elevated areas and lowered        areas cover a larger part of one side of said penile implant,        than of the opposite side of said penile implant.    -   According to another aspect there is provided a penile implant,        in particular a penile implant for curing erectile impotence,        wherein said penile implant is adapted to be implanted in the        corpus cavernosum of a penis. Further may said penile implant be        adapted to be post-operatively adjustable. Said penile implant        may comprise a pre-formed section which is positioned at a point        or in an area of said penile implant which is in the vicinity of        and/or includes the position where the protruding part of the        penis stark. Said preformed section is formed in such a way that        bending creases are avoided or reduced when said penile implant        is implanted and the penis is in a relaxed or flaccid position,        suitably hanging in a relaxed or flaccid position.    -   The penile implant may optionally have the following further        characteristics:    -   According to one embodiment there is provided a penile implant        wherein said pre-formed section comprises at least one fold,        pleat, bellow shaped part or part having a smooth surface, or        combinations thereof. Said pre-formed section may have a        longitudinal extension in the interval of around 1 to 100 mm.    -   According to another embodiment there is provided a penile        implant wherein said pre-formed section is expandable.    -   According to a further embodiment there is provided a penile        implant which is adapted to be non-invasively adjustable.    -   According to yet another embodiment there is provided a penile        implant wherein said penile implant is adapted to selectively        assume a first in-activated state, in which said penile implant        may be collapsed, and a second activated state, in which said        penile implant may be expanded.    -   According to yet a further embodiment there is provided a penile        implant wherein at least said pre-formed section is hollow or        comprises a hollow body.    -   According to one embodiment there is provided a penile implant        wherein said penile implant is substantially completely hollow        or comprises a hollow body extending along substantially the        complete length of said penile implant.    -   According to another embodiment there is provided a penile        implant which may comprise a transportable medium, e.g. a fluid.        The transportable medium is adapted to be received into and        pressurize said pre-formed section and/or said penile implant        and/or said hollow body, to bring said penile implant into said        second activated state. The transportable medium may as well be        adapted to be withdrawn from said pre-formed section and/or said        penile implant and/or said hollow body, to bring said penile        implant into said first in-activated state.    -   According to a further embodiment there is provided a penile        implant wherein said pre-formed section and/or said penile        implant and/or said hollow body, is adapted to receive, and be        pressurized by, a fluid to bring said penile implant (10) into        said second activated state. Further said pre-formed section        and/or said penile implant and/or said hollow body may be        adapted to release said fluid, or adapted so that said fluid may        be withdrawn therefrom, to bring said penile implant into said        first in-activated state.    -   According to a further aspect there is provided a penile        implant, in particular a penile implant for curing erectile        impotence, wherein said penile implant may be adapted to be        implanted in the corpus cavernosum of a penis of a person.        Further may said penile implant be adapted to be        post-operatively adjustable.    -   Said penile implant may as well be adapted to selectively assume        an in-activated state whereby said penis can be made flaccid,        and an activated state whereby said penis can be erected or made        erected.    -   Said penile implant may be collapsed in its inactivated state        and expanded in its activated state.    -   Said penile implant may have a relatively short proximal portion        which is suited to be placed or located in the mot of the penis,        and a flexible relatively long distal portion, which is suited        to be placed so as to extend along or to be located in the        pendulous or protruding part of the penis.    -   Said penile implant may further comprise a bending portion        placed or located between the proximal and the distal portion,        or in the vicinity of the position where the proximal and the        distal portion meet.    -   Said bending portion may be adapted to enable said penile        implant, when said penile implant is implanted and activated, to        bring at least the pendulous or protruding portion of the penis        to a position in which the penis has an acute angle with the        vertical plane when said person is standing. That is, a position        in which at least the pendulous or protruding portion of the        penis is upwardly bent when said person is standing.

The penile implant may optionally have the following furthercharacteristics:

-   -   According to one embodiment there is provided a penile implant        wherein said bending portion may comprise a pliable or elastic        wall part of said penile implant. Said wall part extends along a        part of, along park of, or along the complete, circumference of        said penile implant. Said wall part extends in such a way as to,        when said penile implant is implanted and activated, bring at        least the pendulous part of the penis to a position in which the        penis has an acute angle with the vertical plane when said        person is standing.    -   According to another embodiment there is provided a penile        implant wherein said wall part extends along at least a part of        the underside, and along at least a part of the upper side of        said penile implant. Said wall part has a greater longitudinal        extension on the underside than on the upper side of said penile        implant (10), when said penile implant (10) is activated and/or        inactivated. This in order to, when said penile implant is        implanted and activated, bring at least the pendulous part of        the penis to a position in which the penis has an acute angle        with the vertical plane when said person is standing.    -   According to a further embodiment there is provided a penile        implant wherein said bending portion comprises a bellows        structure which extends along a part of, along parts of, or        along the complete, circumference of said penile implant. Said        bellows structure is designed so that at least part of the        underside of said penile implant shows a greater length        expansion when said penile implant is activated than the upper        side of said penile implant. This in order to, to, when said        penile implant is implanted and activated, bring at least the        pendulous part of the penis to a position in which the penis has        an acute angle with the vertical plane when said person is        standing.    -   According to yet another embodiment there is provided a penile        implant wherein said bellows structure extends along at least a        part of the underside, and along at least a part of the upper        side of said penile implant.    -   Said bellows structure may have a greater longitudinal extension        on the underside than on the upper side of said penile implant.        Further may said bellows structure have a greater depth, at        least when said penile implant is in it's in or non-activated        state, on the underside than on the upper side of said penile        implant. This in order to, when said penile implant is implanted        and activated, bring at least the pendulous part of the penis to        a position in which the penis has an acute angle with the        vertical plane when said person is standing.    -   According to one embodiment there is provided a penile implant        wherein said bending portion is positioned at a point or in an        area of said penile implant which is in the vicinity of and/or        including the position where the pendulous or protruding part of        the penis stark.    -   According to another embodiment there is provided a penile        implant wherein said bending portion is positioned at or on said        proximal portion, suitably in the vicinity of the position where        said proximal portion and said distal portion meet.    -   According to a further embodiment there is provided a penile        implant which is adapted to be non-invasively adjustable.    -   According to yet another embodiment there is provided a penile        implant wherein at least said bending portion is hollow or        comprises a hollow body.    -   According to yet a further embodiment there is provided a penile        implant which is substantially completely hollow or comprises a        hollow body extending along substantially the complete length of        said penile implant.    -   According to one embodiment there is provided a penile implant        which comprises a transportable medium, e.g. a fluid. Said        transportable medium is adapted to be received into and        pressurize said bending portion and/or said penile implant        and/or said hollow body in order to bring said penile implant        into said second activated state. Said transportable medium may        as well be adapted to be withdrawn from said bending portion        and/or said penile implant and/or said hollow body, to bring        said penile implant into said first in-activated state.    -   According to another embodiment there is provided a penile        implant wherein said bending portion and/or said penile implant        and/or said hollow body, is adapted to receive, and be        pressurized by, a fluid to bring said penile implant into said        second activated state. Further may said bending portion and/or        said penile implant and/or said hollow body be adapted to        release said fluid, or adapted so that said fluid may be        withdrawn therefrom, to bring said penile implant into said        first in-activated state.    -   According to a further embodiment there is provided a penile        implant wherein said bending portion comprises that said        proximal portion has a pliable top wall and a pliable bottom        wall. Said bottom wall is designed to longitudinally distend        more than said top wall, when said penile implant is brought        into said second activated state by said transportable medium.        This in order to cause said distal portion to bend upwardly in        relation to said proximal portion    -   According to yet another embodiment there is provided a penile        implant wherein said bottom wall of said proximal portion forms        circumferentially extending alternating ridges and grooves. Said        bottom wall thereby behaves like an expanding bellows when said        penile implant is brought into said second activated state by        said transportable medium    -   According to yet a further embodiment there is provided a penile        implant wherein said ridges of said bottom wall are spaced apart        from one another, when said penile implant is in its inactivated        state.    -   According to one embodiment there is provided a penile implant        wherein said top wall forms circumferentially extending        alternating ridges and grooves. These ridges and grooves are        dimensioned such that said top wall longitudinally distends less        than said bottom wall, when said penile implant is brought into        said second activated state by said transportable medium.    -   According to another embodiment there is provided a penile        implant wherein said grooves are wedge-shaped.    -   According to a further embodiment there is provided a penile        implant wherein said ridges have a polygonal cross-section.    -   According to yet another embodiment there is provided a penile        implant wherein said distal portion of said penile implant        comprises circumferentially extending alternating ridges and        grooves. Thereby said distal portion behaves like an expanding        bellows and longitudinally prolongs, when said penile implant is        brought into said second activated state by said transportable        medium    -   According to yet a further embodiment there is provided a penile        implant wherein said proximal portion of said penile implant is        made of an elastic material.    -   According to one embodiment there is provided a penile implant        wherein said top wall of said proximal portion is substantially        thicker than said bottom wall of said proximal portion.    -   According to a further embodiment there is provided a penile        implant wherein said elastic material comprises silicone        elastomer.    -   According to yet another aspect there is provided a penile        implant, in particular a penile implant for curing erectile        impotence. Said penile implant may be adapted to be implanted in        the corpus cavernosum of a penis of a person. Said penile        implant is at least partly hollow and/or at least partly        comprises a hollow body. Said penile implant comprises a foam        material transparent for fluid, said foam material is at least        partly filling said penile implant and/or said hollow body.    -   Suitably said foam material has a lower density than water. Said        penile implant and/or said hollow body is adapted to be filled        with said foam material and said fluid so that said foam        material and said fluid together substantially fill the volume        of said penile implant and/or said hollow body.

The penile implant may optionally have the following furthercharacteristics.

-   -   According to one embodiment there is provided a penile implant        wherein said foam material comprises open spaces that can be        filled with said fluid.    -   According to another embodiment there is provided a penile        implant wherein said foam material is a closed cellular foam        material which comprises closed spaces, suitably bubbles. The        closed spaces may contain, or may be filled with, a solid        material, a gas or a fluid, e.g. air or foam material.    -   According to a further embodiment there is provided a penile        implant wherein said penile implant is adapted to be        non-invasively adjustable.    -   According to yet another embodiment there is provided a penile        implant, which is adapted to selectively assume a first        in-activated state, wherein said penile implant may be        collapsed, and a second activated state, wherein said penile        implant may be expanded.    -   According to yet a further embodiment there is provided a penile        implant wherein said fluid is adapted to be received into and        pressurize said penile implant and/or said hollow body, to bring        said penile implant into said second activated state. Said fluid        may also be adapted to be withdrawn from said penile implant        and/or said hollow body, to bring said penile implant into said        first in-activated state.    -   According to one embodiment there is provided a penile implant        wherein said penile implant and/or said hollow body, is adapted        to receive, and be pressurized by, a fluid to bring said penile        implant (10) into said second activated state. Said penile        implant and/or said hollow body may also be adapted to release        said fluid, or adapted so that said fluid may be withdrawn, to        bring said penile implant into said first in-activated state.    -   According to yet a further aspect there is provided a penile        implant, which may be a penile implant for curing erectile        impotence. Said penile implant may be elongated and may be        adapted to be implanted in the corpus caverno sum of a penis of        a person. Said penile implant may also be adapted to        post-operatively be adjustable.    -   Said penile implant may comprise at least one expandable portion        and is adjustable between a first collapsed state and at least        one other, partly or fully expanded, state. In the collapsed        state the at least one expandable portion is collapsed, and in        the other, partly or fully expanded, state said at least one        expandable portion is partly or fully expanded.    -   Said at least one expandable portion may comprise at least one        item chosen from the group consisting of; a radially expandable        portion, a radially expandable segment, a longitudinally        expandable portion, and a longitudinally expandable segment.    -   Said penile implant may have a predetermined shape with a length        and a diameter and may be adapted to allow an increase of the        penile implant diameter and/or length when being adjusted from        said first collapsed to said at least one partly or fully        expanded state. This in order to achieve penile erection with        increased penile diameter and/or length when said penile implant        is implanted and partly or fully expanded, as compared to a        relaxed status of the penis.    -   According to yet another aspect there is provided a penile        implant, which may be a penile implant for curing erectile        impotence. Said penile implant may be elongated and may be        adapted to be implanted in the corpus cavernosum of a penis of a        person. Said penile implant may be adapted to post-operatively        be adjustable.    -   Said penile implant may comprise at least one expandable portion        and may be adjustable between a first in-activated or collapsed        state and at least one other, partly or fully expanded,        activated state. In the first state said at least one expandable        portion is collapsed and in the other, activated state, said at        least one expandable portion is partly or fully expanded.    -   Said at least one expandable portion may comprise a radially        expandable portion and/or a radially expandable segment at least        partly comprising a cross section presenting at least one        concaveness or indentation. Said cross section may present a        concaveness or indentation facing the urethra of the penis.    -   Said penile implant may have a predetermined shape with a length        and a diameter and may be adapted to allow an increase of the        penile implant diameter when being adjusted from said first        in-activated or collapsed state to said at least one other,        partly or fully expanded, activated state. This in order to        achieve penile erection with increased penile diameter when said        penile implant is implanted and partly or fully expanded, as        compared to a relaxed status of the penis.    -   The penile implant may optionally have the following further        characteristics.    -   According to one embodiment there is provided a penile implant        wherein said radially expandable portion or said radially        expandable segment at least partly comprises a cross section        presenting at least one concaveness or indentation.    -   According to another embodiment there is provided a penile        implant wherein said cross section presents at least two        concavenesses or indentations.    -   According to a further embodiment there is provided a penile        implant wherein said cross section presents a concaveness or        indentation facing the urethra.    -   According to yet another embodiment there is provided a penile        implant which comprises said radially expandable portion or said        radially expandable segment on the part of said penile implant        that is adapted to be placed in the protruding or pendulous part        of the penis.    -   According to yet a further embodiment there is provided a penile        implant wherein said at least one expandable portion comprises a        longitudinally expandable portion or a longitudinally expandable        segment. The longitudinally expandable portion or the        longitudinally expandable segment may comprise a longitudinally        expandable structure that comprises at least one concaveness or        indentation.    -   According to one embodiment there is provided a penile implant        wherein said at least one expandable portion comprises a        longitudinally expandable portion or a longitudinally expandable        segment. The longitudinally expandable portion or the        longitudinally expandable segment may comprise a longitudinal        bellows structure that comprises ridges and grooves that extend        substantially circumferentially along a part of, along parts of,        or along the complete, circumference of said penile implant.    -   According to another embodiment there is provided a penile        implant wherein said longitudinally expandable portion or said        longitudinally expandable segment is present on a proximal part        of said penile implant. The proximal part may be adapted to be        placed in the root part of the penis. The root part of the penis        extends substantially on the inside of the body.    -   According to a further embodiment there is provided a penile        implant wherein said longitudinally expandable portion or said        longitudinally expandable segment is present on a distal part of        said penile implant. Said distal part in suitably adapted to be        placed in the protruding or pendulous part of the penis.    -   According to one embodiment there is provided a penile implant        wherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is sufficiently extended to prevent growth of fibrotic tissue fromdirectly interconnecting said substantially opposing sides to an extentthat compromises the adjustability between a first collapsed state andat least one other, partly or fully expanded, state.

-   -   According to another embodiment there is provided a penile        implant wherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is greater than around 1 mm, greater than around 2 mm, or greater thanaround 3 mm.

-   -   According to yet another embodiment there is provided a penile        implant which is adapted to be non-invasively adjustable.    -   According to a further embodiment there is provided a penile        implant wherein at least said at least one expandable portion is        hollow or comprises a hollow body.    -   According to yet a further embodiment there is provided a penile        implant wherein said penile implant is substantially completely        hollow or comprises a hollow body extending along substantially        the complete length of said penile implant.    -   According to one embodiment there is provided a penile implant        wherein said penile implant comprises a transportable medium,        e.g. a fluid. The transportable medium may be adapted to be        received into and pressurize said at least one expandable        portion and/or said penile implant and/or said hollow body. This        in order to bring said penile implant into said at least one        partly or fully expanded state. The transportable medium may        also be adapted to be withdrawn from said at least one        expandable portion and/or said penile implant and/or said hollow        body, to bring said penile implant (10) into said first        collapsed state.        According to another embodiment there is provided a penile        implant wherein said at least one expandable portion and/or said        penile implant and/or said hollow body, is adapted to receive,        and to be pressurized by, a fluid. This in order to bring said        penile implant into said at least one partly or fully expanded        state. Said at least one expandable portion and/or said penile        implant and/or said hollow body may also be adapted to release        said fluid, or adapted so that said fluid may be withdrawn, to        bring said penile implant into said first collapsed state.    -   According to a further embodiment there is provided a penile        implant wherein said penile implant or said hollow body        comprises a first and at least one second compartment both being        adapted to be filled and pressurized with a fluid. The first and        the at least one second compartment are separated by at least        one dividing wall having at least one valve.    -   Said radially expandable segment and said longitudinally        expandable segment may each comprise at least one of a second        compartment, a dividing wall having at least one valve, at least        one invagination.    -   Said at least one second compartment comprises at least one        invagination. Said at least one valve suitably has a first side        or face which is adapted to be closed for fluid up to a        predetermined fluid pressure threshold. For fluid pressures        above said fluid pressure threshold said at least one valve is        adapted to open. Said at least one valve suitably also has a        second side or face which is adapted to be open for fluid at        substantially any pressure, at least for a pressure greater than        zero.    -   Said at least one invagination is adapted to bulge when        subjected to fluid pressure and to resume its invaginated form        when said fluid pressure is removed.    -   According to yet a further embodiment there is provided a penile        implant wherein said first compartment is adapted to be        connected to a source of pressurized fluid.    -   Said first side or face of said at least one valve is suitably        facing said first compartment and said second side or face of        said at least one valve is suitably facing said at least one        second compartment. This is in order to enable that said at        least one second compartment can be filled and pressurized with        fluid when the fluid pressure in said first compartment exceeds        said fluid pressure threshold so that said at least one        invagination bulges and hence prolongs or radially expands said        penile implant and/or hollow body.    -   According to yet another embodiment there is provided a penile        implant wherein said penile implant or said hollow body        comprises a longitudinally expandable portion having a first and        a second hollow portion. The first and the second hollow portion        are each adapted to be filled and pressurized with a fluid, they        may be connected by an elastic first conduit, and optionally        also by an elastic second conduit. The first and the second        hollow portion may as well be connected by an elastic connecting        portion.    -   At least one of, and suitably each of, said first and second        hollow portions comprises at least one invagination. Said        invagination is suitably adapted to bulge when subjected to        fluid pressure and to resume its invaginated form when said        fluid pressure is removed.    -   According to one embodiment there is provided a penile implant        wherein each of said first and second hollow portions comprises        an invagination. Said invaginations are suitably facing each        other and are adapted to bulge and mutually exert a force on        each other when subjected to fluid pressure. This in order to        prolong said penile implant and/or hollow body when said first        and second hollow portions are filled and pressurized with a        fluid. Said invaginations are suitably adapted to resume their        invaginated form when said fluid pressure is removed so that        said penile implant and/or hollow body resumes its not prolonged        length.        In another aspect there is provided a surgery method where a        penile implant as described above is implanted in the patient.        In a further aspect there is provided a system that comprises a        penile implant as described above.        In one embodiment the system comprises at least one switch        implantable in the patient for manually and non-invasively        controlling the penile implant.        In one embodiment the system comprises a hydraulic device having        an implantable hydraulic reservoir, which is hydraulically        connected to the penile implant, wherein the penile implant is        adapted to be non-invasively regulated by manually pressing the        hydraulic reservoir.        In one embodiment the system comprises a wireless remote control        for non-invasively controlling the penile implant. The wireless        remote control may comprise at least one external signal        transmitter and/or receiver, further comprising an internal        signal receiver and/or transmitter implantable in the patient        for receiving signals transmitted by the external signal        transmitter or transmitting signals to the external signal        receiver.        In one embodiment the wireless remote control transmits at least        one wireless control signal for controlling the penile implant.        In one embodiment the wireless control signal comprises a        frequency, amplitude, or phase modulated signal or a combination        thereof.        In one embodiment the wireless remote control transmits an        electromagnetic carrier wave signal for carrying the control        signal.        One embodiment comprises a wireless energy transmission device        for non-invasively energizing implantable energy consuming        component of the penile implant with wireless energy.        In one embodiment there is provided a wave signal selected from        the following: a sound wave signal, an ultrasound wave signal,        an electromagnetic wave signal, an infrared light signal, a        visible light signal, an ultra violet light signal, a laser        light signal, a micro wave signal, a radio wave signal, an x-ray        radiation signal and a gamma radiation signal. The signal may be        an analogue signal, a digital signal, or a combination of an        analogue and digital signal        The wireless energy may be different in different embodiments,        for example: an electric field, a magnetic field, or a combined        electric and magnetic field.        The control signal may be different in different embodiments,        for example an electric field, a magnetic field, or a combined        electric and magnetic field.        In another embodiment there is provided an implantable internal        energy source for powering implantable energy consuming        component of the penile implant.        In one embodiment there is provided an external energy source        for transferring energy in a wireless mode, wherein the internal        energy source is chargeable by the energy transferred in the        wireless mode.        In one embodiment there is provided a sensor or measuring device        sensing or measuring a functional parameter correlated to the        transfer of energy for charging the internal energy source, and        a feedback device for sending feedback information from inside        the patients body to the outside thereof, the feedback        information being related to the functional parameter sensed by        the sensor or measured by the measuring device.        One embodiment further comprises a feedback device for sending        feedback information from inside the patient's body to the        outside thereof, the feedback information being related to at        least one of a physical parameter of the patient and a        functional parameter related to the penile implant.

In one embodiment there is provided a sensor and/or a measuring deviceand an implantable internal control unit for controlling the penileimplant in response to information being related to at least one of aphysical parameter of the patient sensed by the sensor or measured bythe measuring device and a functional parameter related to the penileimplant sensed by the sensor or measured by the measuring device. Thephysical parameter may be a pressure or a motility movement.

In one embodiment there is provided an external data communicator and animplantable internal data communicator communicating with the externaldata communicator, wherein the internal communicator feeds data relatedto the penile implant or the patient to the external data communicatorand/or the external data communicator feeds data to the internal datacommunicator.In one embodiment there is provided a motor or a pump for operating thepenile implant.In one embodiment there is provided a hydraulic operation device foroperating the penile implant.In one embodiment there is provided an operation device for operatingthe penile implant, wherein the operation device comprises a servodesigned to decrease the force needed for the operation device tooperate the penile implant instead the operation device acting a longerway, increasing the time for a determined action.In one embodiment there is provided a operation device for operating thepenile implant, wherein the wireless energy is used in its wirelessstate to directly power the operation device to create kinetic energyfor the operation of the penile implant, as the wireless energy is beingtransmitted by the energy-transmission device.In one embodiment there is provided an energy-transforming device fortransforming the wireless energy transmitted by the energy-transmissiondevice from a first form into a second form energy.In one embodiment the energy-transforming device directly powersimplantable energy consuming component of the penile implant with thesecond form energy, as the energy-transforming device transforms thefirst form energy transmitted by the energy-transmission device into thesecond form energy.In one embodiment the second form energy comprises at least one of adirect current, pulsating direct current and an alternating currentIn one embodiment there is provided an implantable accumulator, whereinthe second form energy is used at least partly to charge theaccumulator.In one embodiment the energy of the first or second form comprises atleast one of magnetic energy, kinetic energy, sound energy, chemicalenergy, radiant energy, electromagnetic energy, photo energy, nuclearenergy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.In one embodiment there are provided implantable electrical componentincluding at least one voltage level guard and/or at least one constantcurrent guard.In one embodiment there is provided a control device for controlling thetransmission of wireless energy from the energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming component of the penile implant fordirectly or indirectly supplying received energy thereto, the systemfurther comprising a determination device adapted to determine an energybalance between the energy received by the internal energy receiver andthe energy used for the implantable energy consuming component of thepenile implant, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.In one embodiment the determination device is adapted to detect a changein the energy balance, and the control device controls the transmissionof wireless energy based on the detected energy balance change.In one embodiment the determination device is adapted to detect adifference between energy received by the internal energy receiver andenergy used for the implantable energy consuming components of thepenile implant, and the control device controls the transmission ofwireless energy based on the detected energy difference.In one embodiment the energy-transmission device comprises a coil placedexternally to the human body, further comprising an implantable energyreceiver to be placed internally in the human body and an electriccircuit connected to power the external coil with electrical pulses totransmit the wireless energy, the electrical pulses having leading andtrailing edges, the electric circuit adapted to vary first timeintervals between successive leading and trailing edges and/or secondtime intervals between successive trailing and leading edges of theelectrical pulses to vary the power of the transmitted wireless energy,the energy receiver receiving the transmitted wireless energy having avaried power.In one embodiment the electric circuit is adapted to deliver theelectrical pulses to remain unchanged except varying the first and/orsecond time intervals.In one embodiment the electric circuit has a time constant and isadapted to vary the first and second time intervals only in the range ofthe first time constant, so that when the lengths of the first and/orsecond time intervals are varied, the transmitted power over the coil isvaried.In one embodiment there is provided a system comprising an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmit wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.In one embodiment there is a an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil, wherein the external second coilof the energy transmitter transmit wireless energy which is received bythe first coil of the energy receiver, the system further comprising afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils.In one embodiment the transmitted energy may be regulated depending onthe obtained coupling factor.In one embodiment there is provided a system wherein the external secondcoil is adapted to be moved in relation to the internal first coil toestablish the optimal placement of the second coil, in which thecoupling factor is maximized.In one embodiment there is provided a system wherein the external secondcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.In a yet further aspect there is provided an operation method using apenile implant or system according to the above further comprising thesteps of a) creating an opening in the skin or penis wall of the malepatient, b) dissecting an one area of the sexually responsive tissue, c)placing the penile implant within said area, adapted to postoperativelystimulate said sexually responsive tissue on patient command.In one embodiment there is provided an operation method comprising thestep of placing an operation device and a power source within the body.In one embodiment the operation method comprises placing a penileimplant comprising placing an integrated unit comprising the penileimplant and an operation device in the same integrated unit.In one embodiment the operation method comprises placing a power sourcecomprising, placing an control unit and a rechargeable battery remotefrom said sexually responsive tissue.In one embodiment the operation method comprises controlling said penileimplant post-operatively and non-invasively from outside the body.In one embodiment the operation method comprises the step of creating anopening in the skin or penis wall of the male patient comprising, a)inserting a tube or needle into the patient body, b) filling the tube orneedle with a gas and thereby expanding a cavity within the male patientbody, c) inserting at least two laparoscopic trocars into said cavity,d) inserting at least one camera trough at least one laparoscopictrocar, e) inserting at least one dissecting tool through at least onelaparoscopic trocar.In one embodiment the penile implant is adapted to be implanted in any,or each, of the corpus cavernosum of the penis of the male patientIn one embodiment the penile implant is adapted to be implanted in thevicinity of, or in contact with, the glans penis of the penis of themale patient.According to one embodiment there is provided a system comprising atleast one penile implant. Said penile implant is adapted to bring apenis to an erected state, when said penile implant is implanted in thecorpus cavernosum of the penis and activated or expanded.

-   -   Said penile implant is suitably adapted to bring a penis to a        flaccid state, when said penile implant is implanted in the        corpus cavernosum of the penis and in-activated or collapsed.        According to a further embodiment there is provided a system        comprising two penile implant. Said penile implants are adapted        to bring a penis to an erected state, when each of said penile        implants is implanted in a corpus cavernosum of the penis of a        person and activated or expanded.    -   Said penile implant are suitably adapted to bring a penis to a        flaccid state, when each of said penile implants is implanted in        the corpus cavernosum of the penis of a person and in-activated        or collapsed.        According to one aspect there is provided a method of implanting        the penile implant in a person or patient.        According to a further aspect there is provided a method of        implanting the system in a person or patient.        In an preferred embodiment, the system comprises at least one        switch implantable in the patient for manually and        non-invasively controlling the penile implant.        In another preferred embodiment, the system comprises a wireless        remote control for non-invasively controlling the penile        implant.        In a preferred embodiment, the system comprises a hydraulic        operation device for operating the penile implant.        In one embodiment, the system comprises comprising a motor or a        pump for operating the penile implant.

BRIEF DESCRIPTION OF THE DRAWINGS

Before the invention described herein is described in detail, it is tobe understood that it is not limited to the particular component part ofthe devices described or process steps of the methods described as suchdevices and methods may vary. It is also to be understood that theterminology used herein is for purposes of describing particularembodiments only, and is not intended to be limiting. It must be notedthat as used in the specification and the appended claims, the singularforms “a,” “an” and “the” also include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “anelement” includes more than one such element, and the like. Theinvention will now be described by way of non limiting embodiments withreference to the accompanying drawings in which a penis is used toexemplify any organ, i.e. the invention is not limited to a penis onlybut may be applied to any organ

FIGS. 1 a and 2 schematically show different embodiment of a system 700implanted in a person,

FIG. 1 b illustrates a system for treating a disease, wherein the systemincludes an penile implant 10 of the invention implanted in a patient,

FIG. 3 is a sectional view showing an implantable device 10 according tothe invention in a collapsed or inactivated state when implanted in thepenis 30 of a patient,

FIG. 4 is a sectional view similar to that of FIG. 3 but showing theimplantable device 10 in an expanded state,

FIGS. 5 a, 5 b are perspective views showing the expandable section 10 chaving different embodiments of the surface structure 100,

FIG. 6 is a sectional view of a surface structure 100 of the implantabledevice 10,

FIG. 7 a is a sectional view similar to that of FIG. 6 but with aslightly different surface structure 100,

FIGS. 7 b-d are drawings showing sections of examples of the surfacestructure 100 described herein,

FIG. 8 schematically shows an embodiment of a penile implant 10 having asurface structure 100,

FIGS. 9 and 10 show examples of different cross sections for a penileprosthesis,

FIGS. 11-13 are drawings showing examples of different surfacestructures,

FIGS. 14-19 schematically show a penile implant 10 comprising someembodiments of the pre-formed section 200, 204, 206,

FIGS. 20-26 schematically show a penile implant 10 comprising someembodiments of the bending portion 300, 302,

FIGS. 27-30 schematically show a penile implant 10 which is hollow andat least partly is filled with a foam material 400, 402,

FIGS. 31-37 schematically show a penile implant 10 having a radiallyexpandable portion 500, 502 and/or a longitudinally expandable portion504. A penile implant 10 comprising a hollow body 12, 12 a, 12 b is alsoschematically shown,

FIGS. 40, 41 schematically show an embodiment where the penile implant10 or hollow body 12, 12 a, 12 b comprises a hollow part, alongitudinally expandable segment 564, respectively radially expandablesegments 572 a, 572 b,

FIG. 42 schematically show an embodiment where the penile implant 10 orhollow body 12, 12 a, 12 b is divided in or comprises a first hollow orexpandable portion 584 and a second hollow or expandable portion 586,

FIGS. 43-57 schematically show various embodiments of the system forwirelessly powering the penile implant shown in FIG. 1 b.

FIG. 58 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of thepenile implant shown in FIG. 1 b.

FIG. 59 schematically shows an embodiment of the system, in which thepenile implant is operated with wire bound energy.

FIG. 60 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the penile implant shown in FIG. 1 b.

FIG. 61 is a circuit for the arrangement shown in FIG. 60, according toa possible implementation example.

FIGS. 62-68 show various ways of arranging hydraulic or pneumaticpowering of an penile implant implanted in a patient.

The system 700 may be a system described as system 1000, the system 1000may as well be a system 700.

The operation device 720 may e.g. comprise at least one device selectedfrom the group consisting of the operation device 1007 and 1008.

The control device 722 may e.g. comprise at least one device selectedfrom the group consisting of the devices 1002, 1006, 1004 and 1041.

The conduit 730 may e.g. comprise at least one device selected from thegroup consisting of the conduits 1011 and 1003.

DETAILED DESCRIPTION

Before the device described herein is described in detail, it is to beunderstood that the device is not limited to the particular componentpart of the devices described or process steps of the methods describedas such devices and methods may vary. It is also to be understood thatthe terminology used herein is for purposes of describing particularembodiments only, and is not intended to be limiting. It must be notedthat as used in the specification and the appended claims, the singularforms “a,” “an” and “the” also include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “anelement” includes more than one such element, and the like. As mentionedabove in connection with the brief description of the drawings, a penisis used to exemplify any organ in the following detailed description,i.e. the invention is not limited to a penis only but may be applied toany organ. Accordingly the feature “penis” also exemplifies other organsas stated in the summary.

In FIGS. 1 and 2 penile prosthesis systems 700 implanted in a standingperson having a penis 30 schematically are shown. FIG. 1 a schematicallyshows a manually operated system having a manual operating device 702implanted in the scrotum. FIG. 2 schematically shows a powered systemhaving a control device 722 and a powered operating device 720. In bothsystems a penile implant 10 is suitably implanted in each corpuscavernosum of the penis 30.

Some features of an implantable device according to the invention willnow be explained with reference to FIGS. 3 and 4, which show a penileimplant 10 implanted in the penis, generally designated 30, of a patientor person. In this embodiment the implantable device 10 comprises threesections: a first inner end section 10 a and a second outer end section10 b, and an expandable section 10 c provided between the first andsecond end sections 10 a, 10 b. The expandable section 10 c may alsoextend along the complete length of the penile implant 10, or theexpandable section 10 c may extend from the first inner end section 10 aand along the rest of the implant 10.

The implantable device 10 is adapted to be adjustable between acollapsed or inactivated state, in which the expandable section 10 c iscollapsed, see FIG. 3, and an expanded state, in which the expandablesection 10 c is expanded, see FIG. 4.

Surface Structure

One part of the invention is a surface structure 100 comprising elevatedareas 101, 110 alternating with lowered areas 102, 112. The outersurface of the expandable section 10 c may at least partly comprise thissurface structure to provide the mentioned expandability. Theconfigurations and design of the surface structure 100 will be describedin more detail below with reference to FIGS. 5-13.

Examples of the surface structure 100 are shown in perspective in FIGS.5 a, 5 b, showing the expandable section 10 c partly having a surfacestructure 100.

Referring to FIG. 6, an example of the surface structure 100 comprisingalternating elevated areas 101 and lowered areas 102 will be described.The implantable device 10 may comprise the surface structure 100 havingelevated and lowered areas on at least a part of the outer surface ofthe implantable device 10, which makes it at least partially expandableand collapsible. Adjacent elevated and lowered areas are interconnectedby connecting areas 104. A first distance 108 a between two elevatedareas 101, see FIG. 6, is long enough so as to prevent growth offibrotic tissue directly connecting two adjacent elevated areas 101.That is, it may be possible that fibrotic tissue grows on the surface ofthe elevated and lowered areas 101, 102 and the connecting areas 104.However, thanks to the extension of the first distance 108 a, fibrotictissue is prevented from growing directly from one elevated area 101 toanother adjacent elevated area 101.

With the expression “growing directly from one elevated area 101 toanother elevated area 101” it is e.g. meant that fibrotic tissue growsfrom one elevated area 101 to another while not or only to a smallextent growing on a connecting area 104. As indicated at 104 a in FIG.6, the first distance 108 a may be measured within an interval 104 afrom the level of an elevated area 101. The expression “growing directlyfrom one elevated area 101 to another elevated area 101” also includesthe situation that fibrotic tissue grows on adjacent areas, e.g. twoadjacent connecting areas 104, with such a thickness that the fibrotictissue from each adjacent area meet and bridge the distance or spacebetween two elevated areas 101. In such a situation the space betweentwo elevated areas 101 may be partly or completely filled with fibrotictissue.

It may be suitable that also a second distance 108 b corresponding tothe extension of a lowered area 102 has an extension great enough so asto prevent fibrotic tissue from growing directly from one connectingarea 104 to another connecting area 104. With the expression “growingdirectly from one connecting area 104 to another connecting area 104” itis meant that fibrotic tissue grows from one connecting area 104 toanother while not or only to a small extent growing on a lowered area102.

In FIG. 6 a surface structure comprising elevated and lowered areas hasbeen shown, but apart from elevated and lowered areas also many othergeometrical structures may be used where it is possible to fulfill theabove mentioned prevention of growth of fibrotic tissue. In particularthe above mentioned prevention of growth of fibrotic tissue betweenelevated areas and between connecting areas.

Some examples of such other geometrical structures are shown in FIGS. 57and 11-13. In a surface structure comprising ridges and grooves, theridges and grooves may also have different sections, some examples areshown in FIGS. 7 a-7 d.

Referring mainly to FIGS. 6 and 7 a some expressions and aspects willnow be explained. In this application the concept of a first distance108 a, 118 a between adjacent elevated areas 101, 110 is used. With sucha first distance 108 a, 118 a it is meant a distance that is measuredsubstantially from the edge 106, 114 of one elevated area 101, 110 tothe edge 106, 114 of an adjacent elevated area 101, 110. Measuredsubstantially from the edge means that the measurement may be donewithin a first interval 104 a from the level of an elevated area 101,110, the first interval 104 a extending from the level of an elevatedarea 101, 110 towards the level of an adjacent lowered area 102, 112.

In this application also the concept of a second distance 108 b, 118 bbetween adjacent connecting areas 104, 116 is used. With such a seconddistance 108 b, 118 b it is meant a distance that is measuredsubstantially from the connection point between a connecting area 104,116 and a lowered area 102, 112 to another connection point involving anadjacent connecting area 104, 116. Measured substantially from theconnection point means that the measurement may be done within a secondinterval 104 b from the level of a lowered area 102, 112, the secondinterval 104 b extending from the level of a lowered area 102, 212towards the level of an adjacent elevated area 101, 110.

With elevated and lowered areas it is meant areas that lie in differentplanes 103, 105, 120, 122 where the planes are separated by a distance107, 124, 128. The planes may be parallel or substantially parallel butmay also be non-parallel. If the planes are parallel, defining adistance between them is trivial. If the planes are non-parallel (as inFIG. 7 a) a distance between the planes may be defined by a normal 124,128 to one of the planes 120, 122 where the normal extend to a point onan area in another plane 122, 126 and the distance between the planes isequal to the extension of the normal 124, 128. As seen in FIG. 7 a thenormal 124, 128 extends from a plane 120, 122 to a point which isapproximately equally distant from the edges of an area. There are twopossible ways to define the normal or distance between the planes.Taking normal 128 as example, one may define the normal as in 128 a orin 128 b. It may be suitable to define the distance between two planesas the extension of the longest normal, the distance between the planes120 and 122 would then be equal to the extension of normal 128 a. Thisdefinition will be used hereafter.

The elevated and lowered areas may have different shapes, they may beplane or substantially plane but they may also have some kind of curvedshape.

The elevated areas 101, 110 connect to adjacent lowered areas 102, 112by means of connecting areas 104, 116. The connection betweenelevated/lowered areas and connecting areas 104, 116 may comprise aradius of different sizes, bigger or smaller radii. When the radius isvery small there will substantially be an edge 106, 114 connecting theareas.

The expression “expandable section” implies that said section also iscollapsible.

Suitably the implantable device 10 at least partly comprises materialswhich have a high degree of biocompatibility, such materials may becalled physiologically inert, biologically inert or bio compatible.

As said before, an suitable application for such an implantable device10 is a penile prosthesis for curing erectile impotence. The implantabledevice 10 may at least partly be expandable and/or collapsible and theformation of fibrotic tissue on such an implantable device 10 couldimpede the function or even render the function of the implantabledevice 10 impossible. But, an implantable device 10 comprising a surfacestructure 100 as described herein would not be impeded, or at least onlyimpeded to a small degree, in its function.

A penile implant 10 including a surface structure 100 is suitablyadapted to be adjustable between a first state and a second state,suitably a first collapsed state and a second expanded state. The penileimplant may be activated and/or expanded to different degrees, e.g.fully activated or to some degree partly activated. The first state maye.g. be an in-activated state and the second state may e.g. be anactivated state with any degree of activation. The first and secondstates may also be activated states with different degrees ofactivation. The mentioned examples for the first and second state areexamples, the first and second state may be any two states which thepenile implant can assume. Of course it is possible that the penileimplant can assume any number of states.

The meaning of partly activated and fully activated may be illustratedwith a penile implant which is adjustable in size, as discussed in thesection “Summary” . . . . The maximum size of the penile implant isreached when the penile implant is fully activated and by partlyactivating the penile implant to different degrees any size betweenmaximum and minimum may be achieved. The activation may for example beeffected by transporting a transportable medium to a hollow body withinthe implant, but also other means of activation is possible, e.g.mechanical.

Referring in particular to FIGS. 6 and 7 a, in the surface structure 100there may suitably be a specified first distance 108 a, 118 a betweenadjacent elevated areas 101, 110. The distance between adjacent elevatedareas 101, 110 is chosen so that fibrotic tissue cannot bridge the firstdistance 108 a, 118 a between adjacent elevated areas 101, 110. Hence,the first distance 108 a, 118 a between adjacent elevated areas 101, 110is suitably big enough to prevent the formation of fibrotic tissue thatbridges adjacent elevated areas 101, 110.

As mentioned before, there may suitably be a specified second distance108 b, 118 b between adjacent connecting areas 104, 116. The seconddistance 108 b, 118 b between adjacent connecting areas 104, 116 ischosen so that fibrotic tissue can not bridge the second distance 108 b,118 b between adjacent connecting areas 104, 116. Hence, the seconddistance 108 b, 118 b between adjacent connecting areas 104, 116 issuitably big enough to prevent the formation of fibrotic tissue thatbridges adjacent connecting areas 104, 116. Some suitable intervals forthe first and second distances are mentioned in the section “Summary”.

It may also be suitable that a third distance 107, 124, 128 a betweenthe different planes 103, 105, 120, 122, 126 of the elevated and loweredareas is bigger than a certain threshold to facilitate the collapsibleand/or expandable functionality of the implant. IF the third distance107, 124, 128 a is too small the collapsible and/or expandablefunctionality of the penile implant may be limited. A suitable intervalfor the third distance 107, 124, 128 a is 0.5 to 10 mm, more suitable2-8 mm and most suitable 3-7 mm. Also regarding the aspect that thefibrotic tissue should not impede the collapsible/expandablefunctionality of the implantable device it is suitable that the distance107, 124, 128 a is not too small, but suitably in the interval/s asmentioned previously.

The surface structure 100 may include objects or elements of differentgeometrical shapes, for example ridges of different shapes, embossmentsof different shapes and other objects which enable a surface structureas described herein. The area of the elevated areas 101, 110 may be verysmall while still resulting in a surface structure that has the desiredfunctionality. The area of the elevated areas 101, 110 may even bealmost zero, as exemplified in FIG. 7 d. Whereas FIGS. 6 and 7 a-7 dshow cross sections of examples of surface structures 100, FIGS. 5 a, 5b and 11-13 show examples of different surface structures 100 inperspective. The objects or elements in the surface structure 100 may beplaced in rows, ordered in some other way, or may be more or lessrandomly distributed over the surface of the implant. Different types ofobjects may also be used together in the surface structure 100, e.g. acombination of pyramid shaped and cone shaped objects together withridges of some shape.

In FIGS. 8-10 an embodiment of a penile prosthesis or penile implant 10is shown where a surface structure 100 is used, the penile implant 10 isnot shown in full. FIG. 8 shows a longitudinal section of the penileimplant 10 where 140 denotes the surface structure on the upper side ofthe penile implant 10 and 142 denotes the surface structure on the underside of the penile implant 10. As shown in FIG. 8 the surface structure142 on the under side may have a greater extension than the surfacestructure 140 on the upper side of the penile prosthesis. This gives thepenile implant 10 an up-bent position when the penile implant 10 isexpanded. This may be suitable since a normally functioning penis has anup-bent position when erected and it is suitable if a penile prosthesisresembles a normally functioning penis. This aspect is more closelydiscussed in the parts of the application covering the aspect bendingportion 300, 302, 302. The surface structures 140 and 142 are oneexample of a bending portion 300, 302, 302. FIG. 9 shows a cross sectionof the penile implant 10 where the penile implant 10 includes a waistportion 144, where the waist portion comprises waist surface structures146 and 148. The waist portion with the waist surface structures 146 and148 make the penile implant 10 expandable also in the radial direction.The penile implant 10 may also have a cross section as shown in FIG. 10comprising a waist portion 144 having four waist surface structures 150,152, 154, 156 further facilitating the ability of the penile implant 10to be expandable also in the radial direction. The cross sections inFIGS. 9 and 10 are taken along the line A1-A2 in FIG. 8. Radial andlongitudinal expandability and means therefore is described more closelyin the parts of the application covering the features radiallyexpandable section 500, 502 and longitudinally expandable section 504.

Pre-Formed Section

In FIGS. 14-19 some embodiments of the pre-formed section are shown.Each embodiment is shown both when the penile implant 10 is in itscollapsed or inactivated state, FIGS. 14, 16 and 18, and when the penileimplant 10 is in an activated and/or expanded state, FIGS. 15, 17 and19. In FIGS. 14 and 15 the pre-formed section 200 comprises a bellowshaped first inner pre-formed part 201 and a bellow shaped second outerpre-formed part 202. This embodiment is suitable e.g. since it ispossible to give the different parts 201, 202 different radii so thatthe penis 30 will have a natural appearance when the penile implant 10is implanted and collapsed or inactivated. Also from the aspect ofreducing or avoiding bending creases in the penile implant 10 it may bean advantage to design different parts of the pre-formed sectiondifferently. In case the pre-formed section comprises a bellow shapedpart e.g. the depth of the bellow structure and the extension of theridges and grooves in a direction transversal to the longitudinaldirection of the penile implant may be altered. As shown in FIG. 1 a 5the pre-formed section 200 is designed so that the penis 30 adopts asubstantially straight shape when the penile implant 10 is implanted andactivated and/or expanded.

In FIGS. 16 and 17 the pre-formed section 204 comprises an even surfaceand is pre-formed so that bending creases are avoided or reduced whenthe penile implant 10 is implanted and the penis is in a relaxedposition, and so as to give the penis 30 a natural appearance when thepenile implant 10 is implanted and collapsed or inactivated. As shown inFIG. 1 a 7 the pre-formed section 204 is also designed so that the penis30 adopts a substantially straight shape when the penile implant 10 isimplanted and activated and/or expanded. This can be achieved e.g. byforming the underside of the pre-formed section 204 of a material havinggreater elasticity than the material of the upper side of the pre-formedsection 204, so that the underside of the pre-formed section 204 shows agreater longitudinal expansion than the upper side when the penileimplant 10 is activated and/or expanded. Activation or expansion of thepenile implant 10 may e.g. comprise filling the same with a pressurizedtransportable medium, e.g. a fluid.

In FIGS. 18 and 19 the pre-formed section 206 comprises a fold or pleatdesigned so that bending creases are avoided or reduced when the penileimplant 10 is implanted and the penis is in a relaxed position, and soas to give the penis 30 a natural appearance when the penile implant 10is implanted and collapsed or inactivated. As shown in FIG. 19 thepre-formed section 206 is also designed so that the penis 30 adopts asubstantially straight shape when the penile implant 10 is implanted andactivated and/or expanded.

As seen in FIG. 20 the penis 30 can be said to have a pendulous penisportion 30 b, extending outside the body and being the part to the leftof the line 30 a, and a mot penis portion 30 c extending inside the bodyand being the part to the right of the line 30 a. The penile implant 10has a distal portion 10 d located in the pendulous penis portion 30 band a proximal portion 10 e located in the mot penis portion 30 c.

Bending Portion

In FIGS. 20-26 the aspect bending portion is illustrated. In FIG. 20 onesuitable location on the penile implant 10 of a bending portion 300, 302is illustrated. The penile implant 10 is implanted in the corpuscavernosum of a penis 30. The penile implant 10 is connected to apowered operating device 702 and a control device 704 and is part of apenile prosthesis system. Of course a penile implant 10 according to anyembodiment and comprising any aspect or feature described herein, orcombination thereof, can be connected to a powered operating device 702and a control device 704 and be part of a penile prosthesis system. Thebending portion 300, 302 shown in FIG. 23 a is bellow shaped and thedepth of the bellows structure 304 is greater on the under side of thebending portion 300, 302 than on the upper side. In this way a penileimplant 10 comprising the bending portion 300, 302 will bend upwardlywhen the penile implant 10 is activated and/or expanded since the underside of the bending portion 300, 302 will show a greater longitudinalexpansion than the upper side. In FIG. 23 b a bending portion 300, 302having a pliable top wall 308 a and a pliable bottom wall 308 b inillustrated. The bottom wall 308 b is designed to longitudinally distendmore than the top wall 308 a, when the penile implant 10 is activated,e.g. expanded. In FIGS. 21 and 22 a penile implant 10 comprising abending portion 300, 302 is shown in a collapsed or inactivatedrespectively an activated and/or expanded state. In FIGS. 24-26 abending portion 302 is shown having an alternative embodiment with abellows structure 306 where the underside of the bending portion 302 hasa greater longitudinal extension than the upper side. The function isthe same as is the embodiment shown in FIGS. 21-23. The embodimentsrespectively illustrated in FIGS. 21-23 and 24-26 may also be combined.The bending portion may be of use in any implant where a bendingfunction in desired.

Pre-Filled

In FIGS. 27-30 a penile implant 10 is shown which is hollow or comprisesa hollow body 12, 12 a, 12 b and where the penile implant 10 or hollowbody 12, 12 a, 12 b at least partly is filled with a foam material 400,402. The hollow body is illustrated in FIGS. 31 c, 31 d. In FIG. 28 thefoam material 400 is illustrated by the cross hatched area. As shown inFIG. 29, a foam material 402 comprising closed spaces or compartments404 which contain a gas, e.g. air may also be used. Such a foam material402 is very light which is an advantage as discussed is the summary. Ingeneral, suitably the foam material 400, 402 is of the closed cellulartype. In FIGS. 28 and 29 the penile implant 10 is in an activated state.In FIG. 30 a penile implant 10 as in FIGS. 28 and 29 is shown in arelaxed state. The penile implant 10 in FIGS. 28-30 comprises a bendingportion 300, 302 but the penile implant 10 may of course comprise a foammaterial 400, 402 without having a bending portion 300, 302.

Radial and Longitudinal Expansion

In FIGS. 31-37 and 40-42 a penile implant 10 having a radiallyexpandable portion 500, 502 and/or a longitudinally expandable portion504 is illustrated. In FIG. 31 a two penile implants 10 coupled to amanual operation device 702 are shown. Suitably one penile implant 10 isimplanted in each corpus cavernosum. Generally and in any embodiment, ifthe penile implant 10 is activated by a pressurized fluid suitably thepenile implant 10 is at least partly hollow or at least partly comprisesa hollow body 12, 12 a, 12 b, where the penile implant 10 or the hollowbody 12, 12 a, 12 b is adapted to be filled and pressurized with afluid. In FIGS. 31 c, 31 d the hollow body 12, 12 a, 12 b is shown intwo embodiments, one where the penile implant 10 comprises one hollowbody 12 and another where the penile implant 10 comprises two hollowbodies 12 a, 12 b. The hollow bodies 12, 12 a, 12 b or the penileimplant 10 are/is suitably connected to an operation device 720, 702 bya conduit 730 adapted to convey fluid. In FIG. 32 a penile implant 10implanted in the corpus cavernosum of a penis and connected by a conduit730 to an operation device 702 implanted in the scrotum 34 is shown inits relaxed state. The radially expandable portion 500, 502 may e.g. bewaist formed and comprise two indentations 512, 526 as shown in FIGS. 33a, 33 e or comprise one indentation 530 as in FIG. 33 b and may extendalong substantially the complete length of the penile implant 10. InFIG. 33 c a penile implant 10 is shown where the radially expandableportion 500, 502 extends along a part of the length of the penileimplant 10. The radially expandable portion 500, 502 may e.g. extendfrom a point at approximately 2 or 3 cm distance from the proximal end534 to a point at approximately 1 cm distance from the distal end 536 ofthe penile implant 10. FIG. 34 schematically shows the penile implant 10in FIG. 32 in an expanded state. FIG. 33 a shows a cross section of apenis 30 where a penile implant 10 is implanted in each corpuscavernosum, and has a radially expandable portion 500 comprising twoindentations 512, 526. The penile implants 10 are in their collapsedstate in FIG. 33 a. Reference number 32 denotes the envelope of fibroustissue that surrounds each corpus cavernosum. FIG. 33 d shows the penileimplants 10 in FIGS. 33 a, 33 b in an expanded state. FIG. 33 b shows across section of a penis 30 where a penile implant 10 having a radiallyexpandable portion 502 is implanted in each corpus cavernosum and is inits collapsed state. The radially expandable portion 502 comprises oneindentation 530 which faces the urethra 34. FIG. 33 e shows the distance524 between the substantially opposing sides 512 a and 512 b of theindentation 512 and the depth 518 of the indentation or concaveness 512.As for the surface structure 100, the distance 524 may be measuredwithin an interval 520 from the top or opening 514 of the indentation512 and/or within an interval 522 from the bottom 516 of the indentation512. This is analogous with the definition of the distances 108 a, 108b, 118 a, 118 b. The distance 524 may e.g. be around 3 mm and it issuitable that this means that the distance 524 should be around 3 mm atsome level within the interval 522 and at some level within the interval520. What has been stated about distance and depth for the indentation512 is also valid for the indentations 526 and 530.

FIG. 35 shows a penile implant 10 having a radially expandable portion500, 502 and a longitudinally expandable portion 504. The longitudinallyexpandable portion 504 is located in the area where the proximal portion10 e and distal portion 10 d of the penile implant 10 meet, which is onesuitable location. In FIGS. 36 a, 36 b and 37 a, 37 b the penile implant10 in FIG. 35 is shown in a collapsed respectively in an expanded state.

In FIGS. 40, 41 an embodiment is shown where the penile implant 10comprises a hollow part adapted to be filled and pressurized with afluid, the hollow part may be realized in that the penile implant 10itself is hollow or it may comprise a hollow body 12, 12 a, 12 b. Thehollow part 10, 12, 12 a, 12 b is divided in compartment 560, 562separated by dividing wall(s) 566 having a valve 568 which at a firstside A opens for fluid flow from the first side A when the fluidpressure at the first side A exceeds a certain pressure value butotherwise is closed for fluid flow from the first side A. At the secondside B of the valve 568 the valve opens for fluid flow from the secondside B already when the fluid pressure at the second side is very low,suitably at substantially zero pressure, this to enable emptyingcompartment 562 and collapsing invagination 564. The compartment 562 onthe second side B of the wall 566 has at least one invagination 564.Line 564 i shows the invagination 564 in its invaginated or collapsedform and line 564 ii in its expanded form. In this way a firstcompartment 560 on the first side A of a dividing wall 566 can be filledand pressurized with fluid to make the implant 10 hard and stiff at afirst size, and by further increasing the pressure of the fluid a secondcompartment 562 on the second side B of the dividing wall 566 can befilled and pressurized with fluid to make the implant 10 hard and stiffat a second, greater size when the invagination 564 bulge due to thefluid pressure. Suitably the first compartment 560 is adapted to alwaysbe filled and pressurized with fluid when the implant 10 is activated.Suitably the penile implant 10 is activated in that the operation device702, 722 is controlled to fill and pressurize the first compartment 560with fluid to a first pressure level, where the patient or user of thesystem can select to increase the pressure to fill and pressurize alsothe second compartment 562 to achieve a larger erected penis. The partof the penile implant 10 or hollow body 12, 12 a, 12 b that comprisesthe first compartment 560 may as well comprise a radially and/orlongitudinally expandable portion 500, 502, 504 or any other feature oraspect described herein. Wall part 570 is optional. FIG. 40 shows alongitudinally expandable portion 574 having a compartment 562 forlongitudinal expansion and FIG. 41 two compartments 562 a, 562 b forradial expansion having two radially expandable segments 572 a, 572 b.The invagination 564 in FIG. 41 may e.g. be an indentation 512, 526, or530. Instead of two compartments 562 a, 562 b for radial expansion theremay be provided one compartment 562 for radial expansion having oneradially expandable segment 572, suitable e.g. if the penile implant 10or hollow body 12, 12 a, 12 b has a cross section presenting anindentation 530 as shown in FIG. 33 b.

The radially expandable segment(s) 572, 572 a, 572 b may be adapted toassume any desired radial dimension when the compartment(s) 562, 562 a,562 b are filled with and pressurized by fluid. One example of a radialdimension of the radially expandable segment(s) 572, 572 a, 572 b in theexpanded state is illustrated by the continuous lines indicated by 572a, 572 b. Another example is illustrated by the broken lines indicatedby 576 a, 576 b and illustrating another radial dimension of theradially expandable segment(s) 572, 572 a, 572 b. The radiallyexpandable segment(s) 572, 572 a, 572 b may extend along a part of oralong the whole distal portion of the penile implant 10. If desired, theradially expandable segment(s) 572, 572 a, 572 b may also extend alongthe proximal portion of the penile implant. The compartment 562 andinvagination 564 in FIG. 40 may have any desired size or length toachieve any desired prolongation of the penile implant 10 when thecompartment 562 is filled with and pressurized by fluid. Hence, toachieve any desired prolongation of the penis 30 when the penile implant10 is implanted in a corpus cavernosum of the penis 30 and thecompartment 562 is filled with and pressurized by fluid.Correspondingly, the size of the radially expandable segment(s) 572, 572a, 572 b may be adapted to achieve any desired radial expansion of thepenis 30.

In FIG. 42 an embodiment is shown where the penile implant 10 or hollowbody 12, 12 a, 12 b is divided M a first hollow portion 584 and a secondhollow portion 586 connected by a flexible conduit, e.g. one flexibleconduit 580 a or two flexible conduits 580 a, 580 b, and a flexibleportion 582. Each hollow portion 584, 586 has an invagination 564 a, 564b where the invaginations 564 a, 564 b are facing each other and areadapted to bulge and mutually exert a force on each other when subjectedto fluid pressure, so as to prolong the penile implant 10 and/or hollowbody 12, 12 a, 12 b when the first and second hollow portions 584, 586are filled and pressurized with a fluid, wherein the invaginations 564a, 564 b are adapted to resume their invaginated or collapsed form whenthe fluid pressure is removed so that the penile implant 10 and/orhollow body 12, 12 a, 12 b resumes its not prolonged length. When thepenile implant 10 is activated and the hollow portions 584, 586 arefilled and pressurized with the fluid pumped by the operation device702, 722 the flexible conduits 580 a, 580 b, and the flexible portion582 naturally also prolong. The embodiments in FIGS. 40-42 may naturallybe combined in any way.

Vibrating Unit

In FIGS. 38-39 a vibration device 600 and a penile implant 10 comprisingsuch a device is shown. FIG. 38 a shows one exemplary location of avibration device 600 in each penile implant 10 of a penile prosthesissystem 700. FIG. 38 b schematically shows one exemplary embodiment ofthe vibration device 600 comprising an outer shell 602, a motor 604, afirst motor axis 606, an eccentric element 608 eccentrically mound tothe first motor axis 606, a second axis 610 which suitably is supportedby a bearing mounted to the outer shell 602. FIG. 32 shows a penileimplant 10 having a vibration device 600, implanted in the corpuscavernosum of a penis and connected by a fluid conduit 730 to anoperation device 720 and to a control device 722 in it relaxed state. InFIG. 39 letters a, b, c and d indicates alternative locations for thevibration device 600. The vibration device 600 may of course beimplanted directly in the penis or in the region of the penis and neednot be located in a penile implant 10. FIG. 38 c schematically shows oneexemplary embodiment of the vibration device 600 comprising anelectromagnetic device 620.

Generally, in any embodiment of the penile implant 10 or vibrationdevice 600, a sensor 1070, 1025, 1043 may measure at least onephysiological or functional parameter. The location of the sensor 1070,1025 is adapted to the circumstances, e.g. which parameter that shouldbe measured. The sensor 1070, 1025 may e.g. be connected to the controldevice 722 via a communication line 1072 that also may supply power tothe sensor 1070, 1025.

The control device 722 or operation device 720 may comprise at least oneitem selected from the group consisting of; an energy-transformingdevice 1002, a control unit 1041, a battery 1042, a sensor 1043, a motor1044, a pump 1045, a reservoir 1046 or an injection port 1047. The itemsbeing selected depending on the circumstances, e.g. if the apparatus iselectrically, hydraulically, pneumatically or mechanically operated.

If a non-rechargeable battery is used the energy-transforming device1002 may be omitted but the items 1041 to 1047 may be used as suitable,and be connected to the penile implant 10, vibration device 600 andsensor 1070, 1025, 1043 as suitable. If e.g. the penile implant 10 ishydraulically operated it may e.g. be suitable to use a control unit1041, a pump 1045 and/or a reservoir 1046, the connection to the penileimplant 10 suitably being a hydraulic conduit.

In general, any item, or combinations of items, described and suitedtherefore, may be connected to the penile implant 10 via the powersupply line 1003, 730. The actual item, or combinations of items, beingchosen depending on the circumstances, e.g. if the penile implant 10 iselectrically, hydraulically, pneumatically or mechanically operated.This is valid for any embodiment of the penile implant 10 or vibrationdevice 600, described in any figure.

If e.g. the penile implant 10 is mechanically operated it may beconnected to a motor 1044 via the power supply line 1003, 730 which inthis case may be a wire or bowden cable. A control unit 1041 may beconnected to the motor 1044.

If e.g. the penile implant 10 is electrically operated it may besuitable to connect it to a source of electrical energy 1002 or 1042 viathe power supply line 1003, 730 which in this case may be an electricalconduit. A control unit 1041 or control device 722 may be connected tothe source of electrical energy 1002 or 1042.

System, e.g. a Penile Prosthesis System

FIG. 1 b schematically illustrates a system for treating a diseasecomprising an penile implant 10 of the present invention placed in apatient. An implanted energy-transforming device 1002 is adapted tosupply energy consuming component of the penile implant with energy viaa power supply line 1003. An external energy-transmission device 1004for non-invasively energizing the penile implant 10 transmits energy byat least one wireless energy signal. The implanted energy-transformingdevice 1002 transforms energy from the wireless energy signal intoelectric energy which is supplied via the power supply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedpenile implant 10 is operable in response to the energy of the secondform. The energy-transforming device 1002 may directly power the penileimplant with the second form energy, as the energy-transforming device1002 transforms the first form energy transmitted by theenergy-transmission device 1004 into the second form energy. The systemmay further include an implantable accumulator, wherein the second formenergy is used at least partly to charge the accumulator.Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power the penileimplant, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the penile implant, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the penile implant.The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current.Normally, the penile implant comprises electric components that areenergized with electrical energy. Other implantable electric componentsof the system may be at least one voltage level guard or at least oneconstant current guard connected with the electric components of thepenile implant.Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.The energy-transmission device may be controlled from outside thepatients body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating thepenile implant. Alternatively, the energy-transmission device iscontrolled from outside the patients body to release non-magneticwireless energy, and the released non-magnetic wireless energy is usedfor operating the penile implant.The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the penileimplant. The control signal is received by an implanted signal receiverwhich may be incorporated in the implanted energy-transforming device1002 or be separate there from. The wireless control signal may includea frequency, amplitude, or phase modulated signal or a combinationthereof. Alternatively, the wireless control signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.Alternatively, the wireless control signal comprises an electric ormagnetic field, or a combined electric and magnetic field.The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.FIG. 43 illustrates the system of FIG. 1 b in the form of a moregeneralized block diagram showing the penile implant 10, theenergy-transforming device 1002 powering the penile implant 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatients skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.FIG. 42 shows an embodiment of the invention identical to that of FIG.43, except that a reversing device in the form of an electric switch1006 operable for example by polarized energy also is implanted in thepatient for reversing the penile implant 10. When the switch is operatedby polarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the penile implant 10.FIG. 45 shows an embodiment of the invention identical to that of FIG.43, except that an operation device 1007 implanted in the patient foroperating the penile implant 10 is provided between the implantedenergy-transforming device 1002 and the penile implant 10. Thisoperation device can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.FIG. 46 shows an embodiment of the invention identical to that of FIG.43, except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the penile implant 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to thepenile implant 10 to operate the penile implant, and hydraulic fluid ispumped by the motor/pump unit 1009 back from the penile implant 10 tothe fluid reservoir 1010 to return the penile implant to a startingposition. The implanted energy-transforming device 1002 transformswireless energy into a current, for example a polarized current, forpowering the motor/pump unit 1009 via an electric power supply line1012.Instead of a hydraulically operated penile implant 10, it is alsoenvisaged that the operation device comprises a pneumatic operationdevice. In this case, the hydraulic fluid can be pressurized air to beused for regulation and the fluid reservoir is replaced by an airchamber.In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patients hand most likely indirect, for example a press buttonplaced under the skin. FIG. 47 shows an embodiment of the inventioncomprising the external energy-transmission device 1004 with itswireless remote control, the penile implant 10, in this casehydraulically operated, and the implanted energy-transforming device1002, and further comprising a hydraulic fluid reservoir 1013, amotor/pump unit 1009 and an reversing device in the form of a hydraulicvalve shifting device 1014, all implanted in the patient. Of course thehydraulic operation could easily be performed by just changing thepumping direction and the hydraulic valve may therefore be omitted. Theremote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 1009 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the penile implant 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the penile implant 10 to operatethe penile implant, and another opposite direction in which the fluid ispumped by the motor/pump unit 1009 back from the penile implant 10 tothe hydraulic fluid reservoir 1013 to return the penile implant to astarting positionFIG. 48 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, thepenile implant 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the penile implant 10. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 eitherreleases electric energy from the accumulator 1016 and transfers thereleased energy via power lines 1018 and 1019, or directly transferselectric energy from the implanted energy-transforming device 1002 via apower line 1020, the capacitor 1017, which stabilizes the electriccurrent, a power line 1021 and the power line 1019, for the operation ofthe penile implant 10.The internal control unit is preferably programmable from outside thepatients body. In a preferred embodiment, the internal control unit isprogrammed to regulate the penile implant 10 according to apre-programmed time-schedule or to input from any sensor sensing anypossible physical parameter of the patient or any functional parameterof the system.In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 48 10 may be omitted. In accordance with another alternative,the accumulator 1016 in this embodiment may be omitted.FIG. 49 shows an embodiment of the invention identical to that of FIG.43, except that a battery 1022 for supplying energy for the operation ofthe penile implant 10 and an electric switch 1023 for switching theoperation of the penile implant 10 also are implanted in the patient.The electric switch 1023 may be controlled by the remote control and mayalso be operated by the energy supplied by the implantedenergy-transforming device 1002 to switch from an off mode, in which thebattery 1022 is not in use, to an on mode, in which the battery 1022supplies energy for the operation of the penile implant 10.FIG. 50 shows an embodiment of the invention identical to that of FIG.49, except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of thepenile implant 10. FIG. 51 shows an embodiment of the inventionidentical to that of FIG. 50, except that an accumulator 1016 issubstituted for the battery 1022 and the implanted components areinterconnected differently. In this case, the accumulator 1016 storesenergy from the implanted energy-transforming device 1002. In responseto a control signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe electric switch 1023 to switch from an off mode, in which theaccumulator 1016 is not in use, to an on mode, in which the accumulator1016 supplies energy for the operation of the penile implant 10. Theaccumulator may be combined with or replaced by a capacitor.FIG. 52 shows an embodiment of the invention identical to that of FIG.51, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the penile implant 10.Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the penile implant10.It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.FIG. 53 shows an embodiment of the invention identical to that of FIG.49, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the penile implant 10 (mechanically operated). Even simpleris to switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.FIG. 54 shows an embodiment of the invention identical to that of FIG.60 except that the implanted component are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in it on mode the internal control unit 1015 is permittedto control the battery 1022 to supply, or not supply, energy for theoperation of the penile implant 10.FIG. 55 schematically shows conceivable combinations of implantedcomponent of the penile implant for achieving various communicationoptions. Basically, there are the penile implant 10, the internalcontrol unit 1015, motor or pump unit 1009, and the externalenergy-transmission device 1004 including the external wireless remotecontrol. As already described above the wireless remote controltransmits a control signal which is received by the internal controlunit 1015, which in turn controls the various implanted components ofthe penile implantA feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretc, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the penile implant 10 in response to signals from the sensor1025. A transceiver may be combined with the sensor 1025 for sendinginformation on the sensed physical parameter to the external wirelessremote control. The wireless remote control may comprise a signaltransmitter or transceiver and the internal control unit 1015 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theinternal control unit 1015 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the penile implant 10from inside the patients body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.FIG. 56 shows an alternative embodiment wherein the penile implant 10 isregulated from outside the patients body. The system 1000 comprises abattery 1022 connected to the penile implant 10 via a subcutaneouselectric switch 1026. Thus, the regulation of the penile implant 10 isperformed non-invasively by manually pressing the subcutaneous switch,whereby the operation of the penile implant 10 is switched on and off.It will be appreciated that the shown embodiment is a simplification andthat additional component, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.FIG. 57 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe penile implant.Non-invasive regulation is performed by manually pressing the hydraulicreservoir connected to the penile implant.The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to the penileimplant or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.FIG. 58 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patients body to theoutside thereof to give feedback information related to at least onefunctional parameter of the penile implant or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming component of the penile implant 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the penile implant 10 via a switch 1026. An energy balance isdetermined between the energy received by the internal energy receiver1002 and the energy used for the penile implant 10, and the transmissionof wireless energy is then controlled based on the determined energybalance. The energy balance thus provides an accurate indication of thecorrect amount of energy needed, which is sufficient to operate thepenile implant 10 properly, but without causing undue temperature rise.In FIG. 58 the patients skin is indicated by a vertical line 1005. Here,the energy receiver comprises an energy-transforming device 1002 locatedinside the patient, preferably just beneath the patient's skin 1005.Generally speaking, the implanted energy-transforming device 1002 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 1002 is adapted to receive wirelessenergy-transmitted from the external energy-source 1004 a provided in anexternal energy-transmission device 1004 located outside the patient'sskin 1005 in the vicinity of the implanted energy-transforming device1002.As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the penile implant, e.g. after storingthe incoming energy in an implanted energy source, such as arechargeable battery or a capacitor. However, the present invention isgenerally not limited to any particular energy transfer technique, TETdevices or energy sources, and any kind of wireless energy may be used.The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted component of the penileimplant. The term “energy used” is then understood to include alsoenergy stored by implanted components of the penile implant. A controldevice includes an external control unit 1004 b that controls theexternal energy source 1004 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 1015 connected between the switch 1026and the penile implant 10. The internal control unit 1015 may thus bearranged to receive various measurements obtained by suitable sensors orthe like, not shown, measuring certain characteristics of the penileimplant 10, somehow reflecting the required amount of energy needed forproper operation of the penile implant 10. Moreover, the currentcondition of the patient may also be detected by means of suitablemeasuring devices or sensors, in order to provide parameters reflectingthe patients condition. Hence, such characteristics and/or parametersmay be related to the current state of the penile implant 10, such aspower consumption, operational mode and temperature, as well as thepatients condition reflected by parameters such as; body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere. Furthermore, an energy source in the form of anaccumulator 1016 may optionally be connected to the implantedenergy-transforming device 1002 via the control unit 1015 foraccumulating received energy for later use by the penile implant 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a rechargeable battery, and themeasured characteristics may be related to the current state of thebattery, any electrical parameter such as energy consumption voltage,temperature, etc. In order to provide sufficient voltage and current tothe penile implant 10, and also to avoid excessive heating, it isclearly understood that the battery should be charged optimally byreceiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the penile implant 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurement are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.Hence, the present solution according to the arrangement of FIG. 58employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming component of the penile implant. The penile implant mayuse the received energy either for consuming or for storing the energyin an implanted energy source or the like. The different parametersdiscussed above would thus be used if relevant and needed and then as atool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally tospecifically operate the penile implant.The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate unit using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmit wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 58, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.To conclude, the energy supply arrangement illustrated in FIG. 58 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement result from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmit wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.With reference to FIG. 59, although wireless transfer of energy foroperating the penile implant has been described above to enablenon-invasive operation, it will be appreciated that the penile implantcan be operated with wire bound energy as well. Such an example is shownin FIG. 59, wherein an external switch 1026 is interconnected betweenthe external energy source 1004 a and an operation device, such as anelectric motor 1007 operating the penile implant 10. An external controlunit 1004 b controls the operation of the external switch 1026 to effectproper operation of the penile implant 10.FIG. 60 illustrates different embodiments for how received energy can besupplied to and used by the penile implant 10. Similar to the example ofFIG. 58, an internal energy receiver 1002 receives wireless energy Efrom an external energy source 1004 a which is controlled by atransmission control unit 1004 b. The internal energy receiver 1002 maycomprise a constant voltage circuit, indicated as a dashed box “constantV” in the figure, for supplying energy at constant voltage to the penileimplant 10. The internal energy receiver 1002 may further comprise aconstant current circuit, indicated as a dashed box “constant C” in thefigure, for supplying energy at constant current to the penile implant10.The penile implant 10 comprises an energy consuming part 10 a, which maybe a motor, pump, restriction device, or any other medical appliancethat requires energy for its electrical operation. The penile implant 10may further comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The penile implant 10 may furthercomprise an energy stabilizing unit 10 c for stabilizing the energysupplied from the internal energy receiver 1002. Thus, the energy may besupplied in a fluctuating manner such that it may be necessary tostabilize the energy before consumed or stored.The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the penile implant 10, before being consumed and/orstored by the penile implant 10. Alternatively, the energy stabilizingunit 1028 may be integrated in the internal energy receiver 1002. Ineither case, the energy stabilizing unit 1028 may comprise a constantvoltage circuit and/or a constant current circuit.It should be noted that FIG. 58 and FIG. 60 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional component and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.FIG. 61 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted component of thepenile implant, more energy is transferred and thus charged into theenergy source. The output signal from the circuit is typically feed toan A/D converter and converted into a digital format. The digitalinformation can then be sent to the external energy-transmission deviceallowing it to adjust the level of the transmitted energy. Anotherpossibility is to have a completely analog system that uses comparatorscomparing the energy balance level with certain maximum and minimumthresholds sending information to external energy-transmission device ifthe balance drifts out of the max/min window.The schematic FIG. 61 shows a circuit implementation for a system thattransfers energy to the implanted energy component of the penile implantof the present invention from outside of the patients body usinginductive energy transfer. An inductive energy transfer system typicallyuses an external transmitting coil and an internal receiving coil. Thereceiving coil, L1, is included in the schematic FIG. 44; thetransmitting part of the system are excluded.The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 61and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 61 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The component in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.Energy to power the circuit is received by the energy receiving coil 11.Energy to implanted component is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is presentattest point Y1.Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 44 could be incorporated in any of theembodiments of FIGS. 47-53, the hydraulic valve shilling device 1014 ofFIG. 47 could be incorporated in the embodiment of FIG. 46, and thegearbox 1024 could be incorporated in the embodiment of FIG. 45. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.The embodiments described in connection with FIGS. 58, 60 and 61identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming component of an electricallyoperable penile implant. Such a method and system will be defined ingeneral terms in the following.A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming component of an penileimplant as described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe penile implant for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the penile implant.The transmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.A system comprising an penile implant as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the penile implant. In itbroadest sense, the system comprises a control device for controllingthe transmission of wireless energy from an energy-transmission device,and an implantable internal energy receiver for receiving thetransmitted wireless energy, the internal energy receiver beingconnected to implantable energy consuming components of the penileimplant for directly or indirectly supplying received energy thereto.The system further comprises a determination device adapted to determinean energy balance between the energy received by the internal energyreceiver and the energy used for the implantable energy consumingcomponent of the penile implant, wherein the control device controls thetransmission of wireless energy from the external energy-transmissiondevice, based on the energy balance determined by the determinationdevice.Further, the system may comprise any of the following:

A primary coil in the external energy source adapted to transmit thewireless energy inductively to a secondary coil in the internal energyreceiver.

The determination device is adapted to detect a change in the energybalance, and the control device controls the transmission of wirelessenergy based on the detected energy balance change

The determination device is adapted to detect a difference betweenenergy received by the internal energy receiver and energy used for theimplantable energy consuming components of the penile implant, and thecontrol device controls the transmission of wireless energy based on thedetected energy difference.

The control device controls the external energy-transmission device todecrease the amount of transmitted wireless energy if the detectedenergy balance change implies that the energy balance is increasing, orvice versa, wherein the decrease/increase of energy transmissioncorresponds to a detected change rate.

The control device controls the external energy-transmission device todecrease the amount of transmitted wireless energy if the detectedenergy difference implies that the received energy is greater than theused energy, or vice versa, wherein the decrease/increase of energytransmission corresponds to the magnitude of said detected energydifference.

The energy used for the penile implant is consumed to operate the penileimplant, and/or stored in at least one energy storage device of thepenile implant

Where electrical and/or physical parameters of the penile implant and/orphysical parameters of the patient are determined, theenergy-transmission device transmit the energy for consumption andstorage according to a transmission rate per time unit which isdetermined by the determination device based on said parameters. Thedetermination device also determines the total amount of transmittedenergy based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to the energy balance, the determination device determines theintegral for a monitored voltage and/or current related to the energybalance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thedetermination device determines the derivative for a monitored voltageand/or current related to the energy balance.

The energy-transmission device comprises a coil placed externally to thehuman body, and an electric circuit is provided to power the externalcoil with electrical pulses to transmit the wireless energy. Theelectrical pulses have leading and trailing edges, and the electriccircuit is adapted to vary first time intervals between successiveleading and trailing edges and/or second time intervals betweensuccessive trailing and leading edges of the electrical pulses to varythe power of the transmitted wireless energy. As a result, the energyreceiver receiving the transmitted wireless energy has a varied power.

The electric circuit is adapted to deliver the electrical pulses toremain unchanged except varying the first and/or second time intervals.

The electric circuit has a time constant and is adapted to vary thefirst and second time intervals only in the range of the first timeconstant, so that when the lengths of the first and/or second timeintervals are varied, the transmitted power over the coil is varied.

The electric circuit is adapted to deliver the electrical pulses to bevaried by only varying the lengths of first time intervals betweensuccessive leading and trailing edges of the electrical pulses.

The electric circuit is adapted to supplying a train of two or moreelectrical pulses in a row, said train having a first electrical pulseat the start of the pulse train and having a second electrical pulse atthe end of the pulse train, and

the lengths of the second time intervals between successive trailingedge of the second electrical pulse in a first pulse train and leadingedge of the first electrical pulse of a second pulse train are varied bythe first electronic circuit

The electric circuit is adapted to provide the electrical pulses aspulses having a substantially constant height and/or amplitude and/orintensity and/or voltage and/or current and/or frequency.

The electric circuit has a time constant, and is adapted to vary thefirst and second time intervals only in the range of the first timeconstant, so that when the lengths of the first and/or second timeintervals are varied, the transmitted power over the first coil arevaried.

The electric circuit is adapted to provide the electrical pulses varyingthe lengths of the first and/or the second time intervals only within arange that includes the first time constant or that is locatedrelatively close to the first time constant, compared to the magnitudeof the first lime constant.

FIGS. 62-65 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted penile implantaccording to the invention.FIG. 62 shows a system as described above with. The system comprises animplanted penile implant 10 and further a separate regulation reservoir1013, a one way pump 1009 and an alternate valve 1014.FIG. 63 shows the penile implant 10 and a fluid reservoir 1013. Bymoving the wall of the regulation reservoir or changing the size of thesame in any other different way, the adjustment of the penile implantmay be performed without any valve, just free passage of fluid any timeby moving the reservoir wall.FIG. 64 shows the penile implant 10, a two way pump 1009 and theregulation reservoir 1013.FIG. 65 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted penile implant10 via a mechanical interconnection 1054. The penile implant has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the penile implant 10.Alternatively, the cavity contains compressible gas, which can becompressed and expanded under the control of the servo reservoir 1050.The servo reservoir 1050 can also be part of the penile implant itself.In one embodiment, the regulation reservoir is placed subcutaneous underthe patients skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 25 a-c. InFIG. 66 a, a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexiblepenile implant 10. In the state shown in FIG. 66 a, the servo reservoir1050 contains a minimum of fluid and most fluid is found in theregulation reservoir 1013. Due to the mechanical interconnection betweenthe servo reservoir 1050 and the penile implant 10, the outer shape ofthe penile implant 10 is contracted, i.e., it occupies less than itsmaximum volume. This maximum volume is shown with dashed lines in thefigure.FIG. 66 b shows a state wherein a user, such as the patient in with thepenile implant is implanted, presses the regulation reservoir 1013 sothat fluid contained therein is brought to flow through the conduit 1011and into the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the penileimplant 10 so that it occupies its maximum volume, thereby stretchingthe stomach wall (not shown), which it contact.The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the penile implant 10in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 67 and 68 a-c. The block diagramshown in FIG. 67 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted penile implant 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the penile implant10.An example of this embodiment will now be described with reference toFIG. 68 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patients skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 68 a, the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the penile implant10. This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe penile implant 10. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.Like in the previous embodiment described above with reference to FIGS.66 a-c, the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the penile implant 10in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.

Of course a penile implant 10 according to any embodiment and comprisingany aspect or feature can be part of a penile prosthesis system 700 andbe connected to a manual or powered operating device 702 and a controldevice 704 and be part of a penile prosthesis system.

Although particular embodiments have been disclosed herein in detail,this has been done by way of example for purposes of illustration only,and is not intended to be limiting with respect to the scope of theappended claims that follow. In particular, it is contemplated by theinventor that various substitutions, alterations, and modifications maybe made to the invention without departing from the spirit and scope ofthe invention as defined by the claims.

1. An implant, adapted to postoperatively be adjustable and comprisingat least one expandable section; wherein said implant is adapted to beadjustable between a first collapsed state, in which said expandablesection is collapsed, and a second expanded state, in which saidexpandable section is expanded, and wherein the outer surface of saidexpandable section at least partly comprises a surface structure havingelevated areas alternating with lowered areas, wherein said expandablesection is adapted to have, in said first collapsed state, a firstdistance between adjacent elevated areas sufficiently extended toprevent growth of fibrotic tissue from directly interconnecting adjacentelevated areas to an extent that compromises the adjustability between afirst collapsed and a second expanded state of said implant said firstdistance being greater than about 1.0 mm, and further comprisingconnecting areas between adjacent elevated and lowered areas, furtheradapted to have, in said first collapsed state, a second distancebetween adjacent connecting areas sufficiently extended to preventgrowth of fibrotic tissue from directly interconnecting adjacentconnecting areas to an extent that compromises the adjustability betweena first collapsed and a second expanded state of said implant saidsecond distance being greater than about 1.0 mm.
 2. An implant accordingto claim 1, wherein said implant is adapted to be noninvasivelyadjustable.
 3. An implant according to claim 1, wherein at least saidexpandable section, is hollow or comprises a hollow body.
 4. An implantaccording to claim 1, wherein said implant is substantially completelyhollow or comprises a hollow body extending along substantially thecomplete length and/or complete volume of said implant.
 5. An implantaccording to claim 3, wherein said implant comprises a transportablemedium, e.g. a fluid, adapted to be received into and pressurize saidexpandable section and/or said implant and/or said hollow body, to bringsaid implant into said second expanded state, or to be withdrawn fromsaid expandable section and/or said implant and/or said hollow body, tobring said implant into said first collapsed state.
 6. An implantaccording to claim 3, wherein said expandable section and/or saidimplant and/or said hollow body, is adapted to receive, and bepressurized by, a fluid to bring said implant into said second expandedstate, and adapted to release said fluid, or adapted so that said fluidmay be withdrawn, to bring said implant into said first collapsed state.7. An implant according to claim 1, wherein said first respectively saidsecond distance is adapted to fulfil said condition of preventingfibrotic tissue from directly connecting adjacent areas when saidimplant is in its second expanded state.
 8. An implant according toclaim 1, wherein the outer surface of said expandable section is atleast partly substantially bellows shaped or substantially corrugated.9. An implant according to claim 1, wherein said implant, seen in crosssection, comprises a waist portion.
 10. An implant according to claim 1,wherein the lowered areas lie in a plane substantially in parallel to aplane of the elevated areas.
 11. An implant according to claim 1,wherein the outer surface of said expandable section at least partlycomprises ridges and grooves.
 12. An implant according to claim 11,wherein said ridges and grooves are substantially parallel.
 13. Animplant according to claim 1, wherein the outer surface of saidexpandable section at least partly comprises protrusions anddepressions.
 14. An implant according to claim 11, wherein the topsurfaces of the ridges and/or the bottom surfaces of the grooves atleast partly have an extension greater than 1 mm in a directiontransversal to the longitudinal direction of the ridges and/or grooves.15. An implant according to claim 1, wherein the distance between aplane of an elevated area and a plane of a lowered area is larger than 1mm to facilitate achieving said first collapsed and/or said secondexpanded state.
 16. An implant according to claim 1, wherein saidexpandable section is preformed into a shape substantially correspondingto the shape assumed by said implant in its first collapsed state. 17.An implant according to claim 1, wherein said alternating elevated areasand lowered areas are distributed over said outside surface of saidimplant so as to facilitate said implant assuming a specific shape whenexpanded.
 18. An implant according to claim 1, wherein said alternatingelevated areas and lowered areas cover a larger part of one side of saidimplant, than of the opposite side of said implant.
 19. An implantaccording to claim 1, wherein said implant is either a penile implant ortwo penile implants for curing erectile impotence, said penile implantsbeing adapted to bring a penis to an erected state, when each of saidpenile implants is implanted in a corpus cavemosum of the penis andactivated or expanded, and said penile implants being adapted to bring apenis to a flaccid state, when each of said penile implants is implantedin the corpus cavemosum of the penis and in-activated or collapsed.20.-62. (canceled)
 63. A method of implanting the implant according toclaim 1, the method comprising at least three of the following steps:creating an opening in the skin or penis wall of the male patient,inserting a tube or needle into the patients body, filling the tube orneedle with a gas and thereby expanding a cavity within the malepatients body, inserting at least two laparoscopic trocars into saidcavity, inserting at least one camera trough at least one laparoscopictrocar, inserting at least one dissecting tool through at least onelaparoscopic trocar, dissecting an one area of the sexually responsivetissue, placing the penile implant within said area, adapted topostoperatively stimulate said sexually responsive tissue on patientcommand, placing the penile implant in at least one of the two corpuscavernosum of the penis, placing the penile implant in contact with theglans penis of the penis, placing an operation device and a power sourcewithin the body, placing an integrated unit comprising the penileimplant and an operation device in the same integrated unit, placing ancontrol unit and a rechargeable battery remote from said sexuallyresponsive tissue, controlling said penile implant post-operatively andnon-invasively from outside the body to bring a penis to an erectedstate, when said penile implant is implanted in the corpus cavernosum ofthe penis and activated or expanded.
 64. (canceled)